1. Introduction

Lung cancer represents approximately 13% of cancer patients and accounts for a high percentage of cancer-related mortality.9 Lung resection is still the main therapeutic rationale. Thence, the count of chest procedures and postthoracotomy pain syndrome (PTPS) continuously rises. Postthoracotomy pain syndrome prevalence could reach 30% to 50%.21 The pain of PTPS is described as moderate to severe in one-fourth of cases and follows both open and video-assisted thoracotomies. It could impair sleep, the patient's psyche, activities of daily living, and overall quality of life (QOL).30 Postthoracotomy pain (PTP) may arise from the rib–periosteal–intercostal nerve complex, yet injury of the intercostal nerve is the main concern in emerging neuropathic PTPS.24,47 Postthoracotomy pain syndromes has several components, the neuropathic one being the cornerstone with myofascial and other pain generators.31,32

The most critical risk factor for developing PTPS is severe unrelieved postoperative pain (ie, pain evokes pain). Therefore, several locoregional and neuraxial techniques have been tried and implemented in multimodal analgesia for that purpose, including thoracic epidural analgesia (TEA), paravertebral block (PVB) besides serratus anterior plane block (SAPB), and recently erector spinae plane block (ESPB).32,46

Postthoracotomy pain syndrome is pain that recurs or persists at the thoracotomy scar at least 2 months after the surgery without infection or cancer recurrence.38Several interventional modalities have been described for treating this type of refractory pain syndrome, such as intrapleural analgesia, intercostal blocks, TEA using steroids, PVB, thoracic sympathectomies, radio frequency therapy of dorsal ganglia, intrathecal drugs delivery, and spinal cord stimulation.1,16 Recently, locoregional analgesic techniques have been successfully used to manage PTPS, including ESPB.11,13

Thoracic epidural analgesia and thoracic paravertebral block (TPVB) are the most used techniques for analgesia after thoracic surgery.34 However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess. Thoracic paravertebral block has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatomal analgesics are required.48

Recently, ESPB was reported as a treatment for thoracic neuropathic pain.26 Erector spinae plane block is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. In addition, the ESPB has the potential to provide both somatic and visceral sensory blockade.26

The selectivity of dexmedetomidine to the α2-receptors is 8 times of its prototype, clonidine. Accordingly, dexmedetomidine has more powerful sedative and analgesic effects than clonidine, with fewer hemodynamic derangements because of α1-receptor activation.6 Dexmedetomidine has been primarily used for sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged anesthesiologists to use it perineurally. Previous studies have declared that dexmedetomidine potentiates local anesthetic effects when administered by the neuraxial route.14 This study aims to evaluate the efficacy of ultrasound-guided continuous ESPB with or without dexmedetomidine compared with TEA in managing acute postoperative pain and possible emergence of PTPS.

2. Methods

This prospective, randomized, controlled, double-blinded study was conducted in Egypt from Mach 2021 to June 2022. The study was approved by the local institutional review board (IRB Number: 201920015.2P) and registered at clinicaltrials.gov under the registry (NCT04531553). The study was conducted following the Helsinki Declaration. After explaining the procedure and obtaining written formal consent, we included 90 patients of both sex scheduled for thoracotomy for thoracic cancer surgeries under general anesthesia (lobectomy, pneumonectomy, and decortication) with the American Society of Anesthesiologists physical status classification I and II, age ≥18 and ≤65 years, and body mass index (BMI) between 20 and 40 kg/m2. The exclusion criteria were patient refusal, known sensitivity or contraindication to local anesthetics or dexmedetomidine, history of psychological disorders, localized infection at the site of block, and uncorrectable coagulopathies (platelet count below 50,000 or an INR > 1.5).

All included patients were randomly divided into 3 equal comparable groups using computer-generated random numbers; each included 30 patients.

Group 1 (n = 30): patients preoperatively received a TEA at the level T5 and T6 with a bolus of 20 mL of levobupivacaine (Chirocaine 0.5%, Abbott, Norway) 0.25%, then levobupivacaine 0.1% infused at a rate of 0.1 mL/kg/h until chest tube removal (usually done at 5–6 days post operation).

Group 2 (n = 30): patients preoperatively received US-guided ESPB on the same side, that is, scheduled operative side, the puncture point of the skin was infiltrated with 2% lidocaine, and once the structures were identified with ultrasound at the level of T5 transverse process, a bolus of 20 mL of levobupivacaine 0.25% was injected on the deep aspect of erector spinae muscle with catheter insertion. A 20 mL of bolus of levobupivacaine 0.1% was injected every 6 hours until chest tube removal.

Group 3 (n = 30): with the same procedure as group 2, the patients received a bolus of 20 mL of levobupivacaine 0.25% and 0.5 μg/kg of dexmedetomidine Hcl (Precedex, Hospira, Inc, Rocky Mount, NC) on the deep aspect of erector spinae muscle, then catheter insertion; 20 mL bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/kg was injected every 6 hours until chest tube removal.

All patients were assessed the day before surgery in a preoperative visit to evaluate their medical status and laboratory investigations and to fulfil all the inclusion and exclusion criteria mentioned above. The patients were instructed on how to report pain using the visual analog scale (VAS) score rating, in which 0 = “no pain” and 10 = “worst possible pain.”

2.1. The technique of thoracic epidural

With aseptic conditions under LA, the epidural space was identified(T5-T6 in midline approach) in sitting position using 18-G Tuohy needle by the loss of resistance to air technique. Then, an 18-G Portex epidural catheter was inserted 5 cm beyond the needle tip and the needle was removed. After checking the patency of the catheter, the catheter was fixed with a fixator, and 2 mL of 0.25% levobupivacaine was given as a test dose. Then, the patient placed in the supine position then another 18 mL of 0.25% bupivacaine was given.

2.2. The ultrasound-guided erector spinae plane block

Ultrasound measurements were performed using a Sonosite Edge (SonoSite, Inc., Bothell, WA) machine and an HFL38X linear transducer (Sonosite Inc) 13 to 16 MHZ.11 The patient was placed in a sitting position under complete aseptic condition, and a cover sheath was used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency, linear, ultrasound transducer placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. This should reveal 3 superficial muscles to the hyperechoic transverse process shadow: trapezius, rhomboid major, and erector spinae. The skin was anesthetized using 3 mL of 2% lidocaine. A 17‐G, 89‐mm R‐X Coudé epidural needle (Epimed, Johnstown, NY) was inserted in plane in a cephaled-to-cauded direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscles, and 20 mL of levobupivacaine 0.25% or a mixture of 20 mL of levobupivacaine 0.25% with 0.5 μg/kg of dexmedetomidine was injected. The injectate included 5 mL of contrast medium iohexol 180 mg I/mL (Omnipaque, Nycomed, Oslo, Norway) (Fig. 1A, B). The location of the needle tip was confirmed by visible fluid spread, lifting the erector spinae muscle off the bony shadow of the transverse process. A reinforced radiopaque epidural catheter (19 G, 14 inches) (BREVI‐KATH Epimed) (RACZ catheter) was threaded and verified by a brief P-A fluoroscopy (Fig. 2A, B).

Figure 1.:

(A) Ultrasonography of pleura (P), transverse process (TP), trapezius, erector spinae (ES), and rhomboid major muscles (R). (B) Ultrasonography showing R-X Coudé needle (N) in contact with the transverse process underneath ES muscle after injection of saline (S).

Figure 2.:

(A) P/A fluoroscopic view showing R-X Coudé needle with the RACZ catheter threaded after contrast injection; (B) Lateral fluoroscopic view showing R-X Coudé needle with the RACZ catheter threaded after the cranial and caudal spread of contrast.

The success of the block was confirmed by the loss of pinprick sensation on the dermatomal site of the block after 30 minutes of injection, and patients with a failed block were excluded.

2.3. Anaesthesia management

Premedication with 0.02 mg/kg of midazolam was administered intravenously 30 minutes preoperatively. All included patients were monitored continuously using electrocardiography, noninvasive blood pressure, peripheral oxygen saturation, and end-tidal carbon dioxide—using the Datex-Ohmeda S5 anesthesia monitor, model no: USE1913A—throughout the surgical procedure. Induction of anesthesia was performed for all groups using a regimen of 2 μg/kg of IV fentanyl, 2 mg/kg of propofol, and 0.5 mg/kg of rocuronium. Anesthesia was maintained with inhaled sevoflurane with MAC 2% to 2.5% in oxygen-enriched air (FiO2 = 50%), and top-up doses of IV rocuronium (0.1 mg/kg) were administered as required. All patients received 1 gm of IV paracetamol. Additional bolus doses of 0.5 µg/kg of fentanyl were given if the mean arterial blood pressure or heart rate rose above 20% of baseline levels and calculated. Patients were mechanically ventilated at appropriate settings that keep end-tidal CO2 at 30 to 35 mm Hg. One reading of mean arterial pressure and heart rate was taken before induction of general anesthesia to be defined as a baseline reading and then regularly recorded immediately before surgical incision and at 30-minute intervals intraoperatively. By the end of the surgery, the residual neuromuscular blockade was reversed using Sugammadex (2 mg/kg), and extubation was performed after complete recovery of the airway reflexes.

All patients were transferred to the postanesthesia care unit where pain scores (VAS), MAP, and heart rate were recorded immediately on arrival, then at 2, 4, 6, 12, and 24 hours postoperatively. The patients were observed in the postoperative care unit for 2 hours, and rescue analgesia was provided as IV morphine 0.1 mg/kg per dose (max 0.3 mg/kg/d) boluses if the pain score was >3. The total amount of morphine given in 24 hours was recorded in the 3 groups. After that, the patients were shifted to the ward, and IV acetaminophen 1 g every 8 hours was prescribed.

Any adverse effects such as nausea, vomiting, hypotension, bradycardia, oversedation, or hematoma were recorded. Postoperative nausea and vomiting (PONV) were rated on a four-point verbal scale3 (none = no nausea, mild = nausea but no vomiting, moderate = vomiting one attack, severe = vomiting > one attack); 0.1 mg/kg of IV ondansetron was given to patients with moderate or severe postoperative nausea and vomiting.

2.3.1. Measurement tools

All measured data were collected by an on‐duty ICU resident unaware of the study.

(1) Duration of the procedure, ICU stay, total hospital stay duration, pathology, lung resection procedure (metastasectomy, wedge resection, lobectomy, pneumonectomy, decortication, pleuropneumonectomy), baseline quality of life scale (QOLS), and pre/postoperative chemo/radiotherapy. (2) VAS score was the primary outcome; it is a horizontal 10‐cm line with zero on the left end indicating no pain and 10 cm on the right end indicating the worst imaginable pain. The average VAS was assessed every 6 hours in the first 24 hours, and then, the average VAS was assessed daily in the first week (both at rest VAS [VAS‐R] and the VAS during coughing or movement, that is, the dynamic VAS [VAS‐D]). The average VAS values were also assessed at 2, 3, 4, 8, and 12 postoperative weeks. (3) Assessment of the possible emergence of PTPS (PTPS incidence) at weeks 8 and 12. The neuropathic PTPS cases were screened using the grading system for neuropathic pain 0 means NO, 1 means possible, 2 probable, and 3 definite positive. Patients with a neuropathic component grade 2 (probable) or 3 (definite) are considered having PTPS.10,39

All patients requiring pain therapy were followed up at the pain clinic. Patients with neuropathic thoracic pain were treated according to the local institutional protocol. From the second postoperative week, pain therapy was offered in the form of adjuvant therapy (pregabalin 75–300 mg/d and/or amitriptyline 10–25 mg/d) plus analgesics “paracetamol or NSAIDs (VAS < 40 mm), tramadol HCl 100 to 600 mg/d (VAS: 40–70 mm), and oxycodone 20 to 80 mg/d (Targin tablets, Mundipharma, 20 mg oxycodone/10 mg naloxone) (VAS ≥ 70 mm).”

(4) Quality of life was assessed using the Flanagan QOLS, a 16‐item (domain) questionnaire with each item scored from 1 to 7 points. The scale was explained to the patients by the pain physician, and the total score was calculated and recorded at the preoperative assessment (baseline) and postoperative weeks 2, 3, 4, 8, and 12.19 (5) The activity level was assessed using the Barthel activities of daily living scale (ADL) at postoperative weeks 2, 3, 4, 8, and 12. This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs, and transfer), with each item scored as 0 = need complete help, 1 = need some help, or 2 = need no help.18 (6) The incidence of adverse events was recorded in all groups. (7) Intraoperative and postoperative opioid consumption was recorded in all groups. 2.4. Sample size calculation

The sample size calculation was done by G*Power 3.1.9.2 (Universitat, Kiel, Germany). We performed a pilot study (5 cases in each group), and we found that the mean (±SD) of resting VAS at 12 hours was 2.4 ± 1.52 in group 1, was 3.4 ± 0.55 in group 2, and was 2.6 ± 1.34 in group 3. The sample size was based on the following considerations: 0.378 effect size, 95% confidence limit, 80% power of the study, 1:1 group ratio, and 18 cases were added to each group to overcome dropout. Therefore, we recruited 90 patients in each group.

2.5. Statistical analysis

Statistical analysis was performed by SPSS version 25 (IBM Inc, Chicago, IL). Shapiro–Wilks normality test and histograms were used to test the distribution of quantitative variables to select accordingly the type of statistical testing: parametric or nonparametric. Parametric variables were expressed as mean and standard deviation (SD) and were compared using the analysis of variance among the 3 groups with post hoc (Tukey) test to compare every 2 groups. Nonparametric variables (eg, VAS) were expressed as the median and interquartile range (IQR) and were analyzed using the Kruskal–Wallis test; Mann–Whitney (U) test was performed to compare every 2 groups. Categorial variables were expressed as frequency and percentage and were statistically analyzed by χ2 test. A 2-tailed P value of ≤0.05 was considered statistically significant.

3. Results

In this trial, 125 cases were assessed for eligibility. Ninety patients were allocated into 3 equal groups. Of these, 4 patients in group 1, 3 in group 2, and 5 in group 3 dropped out during follow-up (Fig. 3).

Figure 3.:

Consort flow diagram of the participants through each stage of the trial. ESP, erector spinae plane.

Baseline characteristics and therapy showed no significant difference between the groups (Table 1).

Table 1 - Baseline characteristics and therapy of the studied patients. Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P Sex 0.877  Male 18 (60%) 17 (56.67%) 16 (53.33%)  Female 8 (26.67%) 10 (33.33%) 9 (30%) ASA 0.099  ASA II 16 (53.33%) 14 (46.67%) 8 (26.67%)  ASA III 10 (33.33%) 13 (43.33%) 17 (56.67%) Age (y) 47.27 ± 9.96 47.41 ± 11.78 50.14 ± 9.78 0.773 Weight (kg) 63.35 ± 5.11 62.19 ± 4.25 62.33 ± 4.43 0.604 Height (m) 1.63 ± 0.07 1.63 ± 0.07 1.61 ± 0.08 0.415 BMI (kg/m2) 23.72 ± 1188.26 23.3 ± 846.31 23.98 ± 624.16 0.738 Therapy  Chemotherapy 9 (30%) 11 (36.67%) 6 (20%) 0.556  Radiotherapy 7 (23.33%) 5 (16.67%) 6 (20%) Lung resection procedures 0.8  Mastectomy 2 (6.67%) 1 (3.33%) 5 (16.67%)  Wedge resection 1 (3.33%) 1 (3.33%) 1 (3.33%)  Pleuropneumonectomy 3 (10%) 3 (10%) 4 (13.33%)  Pneumonectomy 4 (13.33%) 6 (20%) 3 (10%)  Decortication 142.48 ± 11.32 138.9 ± 13.43 143.67 ± 13.03  Lobectomy 2.52 ± 0.51 2.62 ± 0.5 2.57 ± 0.51 Duration of procedure 142.48 ± 11.32 138.9 ± 13.43 143.67 ± 13.03 0.15 ICU stay (d) 2.52 ± 0.51 2.62 ± 0.5 2.57 ± 0.51 0.558 Hospital stays (d) 6.1 ± 0.89 5.86 ± 0.91 6.05 ± 0.86 0.497

Data are presented as mean ± SD or frequency (%).

ASA, American Society of Anesthesiologists; BMI, body mass index; ICU, intensive care unit.

Visual analog scale at rest was significantly higher in group 2 compared with groups 1 and 3 at 6, 24, 36 hours and at 8 and 12 weeks and showed no significant difference between groups 1 and 3 at these measurements. Visual analog scale showed no significant difference between the groups at preoperative, 12, 18, 30, 42, 48 hours, third day, fourth day, fifth day, seventh day, and at 2, 3, and 4 weeks (Table 2).

Table 2 - Visual analog scale score at rest in the studied groups. Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P Preoperative 2.5 (2–3.75) 3 (1.5–4) 3 (2–4) 0.556  6 h 2 (1–3) 3 (2.5–4) 3 (1–3) 0.001 P1= <0.001
P2 = 0.358
P3 = 0.012  12 h 3 (2–3) 3 (2–4) 3 (1–4) 0.687  18 h 2 (1.25–3) 3 (1–4) 2 (2–3) 0.826  24 h 3 (2–4) 5 (4–5) 2 (1–3) <0.001 P1 = 0.03
P2 = 0.051
P3= <0.001  30 h 2 (2–3) 2 (2–4) 2 (1–3) 0.531  36 h 2.5 (2–3.75) 5 (3.5–5) 2 (1–3) <0.001 P1= <0.001
P2 = 0.568
P3= <0.001  42 h 2.5 (2–3) 3 (1–3) 3 (2–4) 0.613  48 h 3 (1.25–4) 2 (1–3) 3 (2–4) 0.188  3 d 1 (0–1.75) 1 (0–1) 1(0–2) 0.604  4 d 1 (0–2) 1 (0–2) 1 (1–2) 0.899  5 d 1 (0–2) 1 (0–1) 1 (0–1) 0.559  6 d 1.5 (1–2) 1(0–2) 1 (0–2) 0.675  7 d 1 (0.25–1.75) 1 (0.5–2) 1(0–1) 0.147  2 wk 1 (0–2) 2 (0.5–2) 1 (0–2) 0.369  3 wk 1 (0–1.75) 1 (0–2) 1 (0–2) 0.408  4 wk 1 (0.25–2) 1 (0–1) 1 (1–2) 0.261  8 wk 0.5 (0–1) 4 (1–6) 0 (0–1) 0.001 P1 = 0.001
P2 = 0.974
P3 = 0.001  12 wk 1 (0.25–1) 2 (1–6) 0 (0–1) <0.001 P1 = 0.007
P2 = 0.262
P3= <0.001

Data are presented as median (IQR), P1: between groups 1 and 2, P2: between groups 1 and 3, P3: between groups 2 and 3.

Visual analog scale at movement was significantly higher in group 2 compared with groups 1 and 3 at 6, 24, 36 hours and 8, and 12 weeks but showed no significant difference between groups 1 and 3 at these measurements. Visual analog scale showed no significant difference between the groups at preoperative, 12, 18, 30, 42, 48 hours, third day, fourth day, fifth day, seventh day, and 2, 3, and 4 weeks (Table 3).

Table 3 - Visual analog scale score at movement in the studied groups. Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P 6 h 2 (2–3.75) 4 (3.5–5) 3 (2–4) <0.001 P1 = <0.001
P2 = 0.475
P3 = 0.001 12 h 3 (2–4) 3 (2.5–4) 3 (2–4) 0.605 18 h 3 (2–4) 3 (2–4) 3 (2–4) 0.674 24 h 3.5 (2.25–4) 5 (4–5) 3 (2–3) <0.001 P1 = 0.002
P2 = 0.088
P3 = <0.001 30 h 3 (3–4) 3 (2–4) 3 (2–4) 0.334 36 h 3 (2–4) 6 (5–7) 3 (2–4) <0.001 P1 = <0.001
P2 = 0.588
P3 = <0.001 42 h 3 (2–3.75) 3 (2–4) 3 (2–4) 0.542 48 h 3(2–4) 2 (1–3.5) 3 (2–4) 0.108 3 d 1 (0–1.75) 1 (0.5–2) 1 (0–2) 0.531 4 d 1 (1–2) 1 (0–1.5) 1 (0–2) 0.481 5 d 1 (0–2) 1 (0–2) 1 (1–2) 0.652 6 d 1 (0–1) 1 (0–1) 1 (0–2) 0.511 7 d 1 (0–2) 1 (0–2) 1 (1–2) 0.767 2 wk 1 (0–2) 1 (0–1) 1 (0–2) 0.982 3 wk 1 (1–2) 1 (0–2) 1 (0–1) 0.222 4 wk 1 (0–2) 1 (0–2) 1 (1–2) 0.594 8 wk 1 (1–2) 2 (1–5) 1 (0–2) 0.033 P1 = 0.062
P2 = 0.516
P3 = 0.012 12 wk 1 (1–2) 2 (1–5) 1 (1–1) 0.025 P1 = 0.255
P2 = 0.118
P3 = 0.007

Data are presented as median (IQR). P1: between groups 1 and 2, P2: between groups 1 and 3, P3: between groups 2 and 3.

Postthoracotomy pain syndrome incidence was significantly higher in group 2 compared with both group 1 and group 3 at 8 and 12 weeks and showed no significant difference between groups 1 and 3.

The grading system for neuropathic pain score was significantly higher in group 2 compared with both group 1 and group 3 at 8 and 12 weeks, whereas it showed no significant difference between groups 1 and 3 (Table 4).

Table 4 - Postthoracotomy pain syndrome and grading system for neuropathic pain in the studied patients. Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P RR (95% CI) PTPS  8 wk 4 (15.38%) 14 (51.85%) 5 (20%) 0.007 P1 = 0.008
P2 = 0.727
P3 = 0.036 0.296 (0.112–0.784)
0.769 (0.232–2.540)
2.592 (1.092–6.152)  12 wk 3 (11.54%) 13 (48.15%) 4 (16%) 0.004 P1 = 0.006
P2 = 0.703
P3 = 0.019 0.239(0.077–0.744)
0.721(0.179–2.903)
3.009 (1.129–8.016) Grading system for neuropathic pain  8 wk   No
  Probable
  Definite 21 (80.8%)
5 (19.2%)
0 (0%) 14 (51.9%)
7 (25.9%)
3 (12%) 21 (84%)
3 (12%)
1 (4%) 0.018 P1 = 0.021
P2 = 0 0.476
P3 = 0.038  12 wk   No
  Probable
  Definite 22 (84.6%)
3 (11.5%)
1 (3.8%) 15 (55.6%)
5 (18.5%)
7 (25.9%) 22 (88%)
0 (0%)
3 (12%) 0.027 P1 = 0.043
P2 = 0.137
P3 = 0.019

Data is presented as median (IQR) and frequencies; PTPS, postthoracotomy pain syndrome; P1: between groups 1 and 2, P2: between groups 1 and 3, P3: between groups 2 and 3.

Intraoperative fentanyl consumption was significantly higher in group 2 compared with group 3 (P value = 0.019) and showed no significant difference between group 1 and groups 2 and 3. Postoperative morphine consumption was significantly higher in group 2 compared with group 1 and group 3 (P value =<0.001, <0.001 respectively) and showed no significant difference between groups 1 and 3 (Table 5).

Table 5 - Intraoperative and postoperative opioids consumption in the studied groups. Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P Intraoperative fentanyl (µg/kg)  Mean ± SD
  Median (IQR) 7.69 ± 15.64
0 (0–0) 16.67 ± 13.89
30 (0–30) 6 ± 13.09
0 (0–0) 0.014 P1 = 0.059
P2 = 0.777
P3 = 0.019 Postoperative morphine (mg/kg/d)  Mean ± SD
  Median (IQR) 12.19 ± 9.41
0 (0–0) 25.15 ± 7.53
30 (0–30) 11.68 ± 7.59
0 (0–0) <0.001 P1= <0.001
P2 = 0.921
P3= <0.001

Data are presented as mean ± SD, P1: P value between groups 1 and 2, P2: P value between groups 1 and 3, P3: P value between groups 2 and 3.

Quality of life showed no significant difference between the groups at baseline and at 2, 3, and 4 weeks. Quality of life at 8 and 12 weeks was significantly higher in both group 1 and group 3 compared with group 2 and showed no significant difference between groups 1 and 3 (Table 6).

Table 6 - Quality of life scale baseline at postoperative weeks 2 to 12 weeks Group 1 (n = 26) Group 2 (n = 27) Group 3 (n = 25) P Baseline 51.31 ± 18.68 40.41 ± 6.78 57.44 ± 22.19 0.316 2 wk 62.65 ± 24.95 60.89 ± 23.65 70.96 ± 25.4 0.383 3 wk 68.54 ± 25.45 56.07 ± 23.02 71.04 ± 24.31 0.081 4 wk 61.65 ± 25.15 58.11 ± 22.13 69.52 ± 25.53 0.335 8 wk 84.46 ± 18.08 63.56 ± 27.56 84.76 ± 19.9 0.004 P1 = 0.049
P2 = 0.321
P3 = 0.003 12 wk 84.54 ± 16.73 64.44 ± 24.07 85.44 ± 16.95 <0.001 P1 = 0.001
P2 = 0.805