Effect of Erector Spinae Plane Block on Postoperative Analgesia and Stress Response in Laparoscopic Sleeve Gastrectomy

NCT07431905 | Completed

• 1 other identifier: HRÜ/23.02.09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation. This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) \>30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30). Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively. Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required. The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.

Conditions

Bariatric Sleeve Gastrectomy; Erector Spina Plan Block; Cortisol; Numerical Rating Scale; Opioid Analgesia

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.

  24 hours after surgery

Secondary Outcomes (15)

• Body Weight (kilograms)

  At baseline (preoperatively)

• Height (centimeters)

  At baseline (preoperatively)

• Body Mass Index (BMI, kg/m²)

  At baseline (preoperatively)

• Postoperative Rescue Opioid Consumption (Intravenous Tramadol, mg)

  During the first 24 hours postoperatively

• Perioperative Heart Rate (beats per minute)

  Intraoperatively and during the first 24 hours postoperatively

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

Procedure: Erector Spinae Plane Block

Group Control

PLACEBO COMPARATOR

Procedure: Control

Interventions

Erector Spinae Plane Block PROCEDURE

Patients in the intervention group received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) in addition to standardized general anesthesia and multimodal analgesia. The block was performed 30 minutes before surgery in the preoperative area by an experienced anesthesiologist under aseptic conditions. With the patient in the prone position, a linear ultrasound probe was placed at the T7-T8 vertebral level to identify the transverse process and erector spinae muscle. Using an in-plane technique, a 22-gauge, 100-mm needle was advanced to the transverse process, and 20 mL of a local anesthetic mixture (lidocaine 2%, bupivacaine 0.25%, and saline) was injected into the fascial plane deep to the erector spinae muscle on each side. Dermatomal sensory assessment was performed before transfer to the operating room. All patients subsequently underwent identical general anesthesia protocols. The control group did not receive any regional block and was managed with the

Group ESPB

Control PROCEDURE

Patients allocated to the control group received standardized general anesthesia and postoperative multimodal analgesia without any regional anesthesia technique. No erector spinae plane block or other peripheral nerve block was performed. General anesthesia induction and maintenance protocols were identical to those used in the intervention group, ensuring comparable intraoperative management. At the end of surgery, all patients received intravenous tramadol as part of the standardized analgesic regimen. Postoperatively, scheduled non-opioid analgesia was administered to all patients. Intravenous tramadol was provided as rescue analgesia when Numerical Rating Scale (NRS) pain scores were ≥4 or upon patient request. Perioperative monitoring, postoperative assessments, and data collection procedures were identical between groups.

Group Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Body mass index (BMI) \> 30 kg/m²
• ASA physical status II-III
• Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
• Ability to provide written and verbal informed consent

You may not qualify if:

• Age \< 18 years or \> 65 years
• ASA physical status I, IV, or V
• Body mass index (BMI) \< 30 kg/m²
• Contraindications to erector spinae plane block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
• Renal or hepatic insufficiency
• Refusal to participate or inability to provide informed consent

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University

Adana, 01360, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 25, 2026
• Study Start: February 5, 2023
• Primary Completion: February 10, 2024
• Study Completion: March 17, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)