Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy (PGB-ESP)
A Prospective Randomized Controlled Trial Comparing the Effects of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain Management Following Laparoscopic Sleeve Gastrectomy
Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid consumption, and reduce patient satisfaction. Effective postoperative pain management is therefore an important component of perioperative care.
Regional analgesia techniques are increasingly used as part of multimodal analgesia protocols to reduce opioid requirements and opioid-related adverse effects. Paragastric nerve block (PGNB) has been reported to provide effective control of visceral pain, nausea, and vomiting after sleeve gastrectomy. Erector spinae plane block (ESPB) is another regional anesthesia technique that has demonstrated efficacy in reducing perioperative opioid consumption in bariatric surgery patients. However, no prospective randomized study has directly compared PGNB and ESPB in patients undergoing sleeve gastrectomy.
This prospective, randomized, controlled clinical trial aims to compare the effects of PGNB, ESPB, and standard analgesia on postoperative pain management following laparoscopic sleeve gastrectomy. Seventy-two adult patients scheduled for elective sleeve gastrectomy will be randomized in a 1:1:1 ratio to receive PGNB, ESPB, or standard multimodal analgesia alone. The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, intraoperative remifentanil consumption, additional analgesic requirements, time to first analgesic request, postoperative nausea and vomiting, and block-related complications.
Study Overview
Status
Intervention / Treatment
Detailed Description
Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric surgical procedures for the treatment of morbid obesity. Although the procedure is minimally invasive, patients commonly experience moderate to severe postoperative pain during the early postoperative period. Inadequate pain control may delay mobilization, prolong hospital stay, increase pulmonary complications, reduce patient satisfaction, and increase opioid consumption, leading to opioid-related adverse effects such as nausea, vomiting, sedation, and respiratory depression.
Regional anesthesia techniques have become an important component of multimodal analgesia protocols aimed at improving postoperative pain control while reducing opioid requirements. Paragastric nerve block (PGNB) is a surgeon-performed regional analgesic technique targeting visceral afferent nerve fibers surrounding the stomach. Previous studies have suggested that PGNB may reduce postoperative pain, opioid consumption, nausea, and vomiting following sleeve gastrectomy. Erector spinae plane block (ESPB) is an ultrasound-guided fascial plane block that has gained popularity in thoracoabdominal surgery because of its ease of application, favorable safety profile, and potential analgesic benefits. ESPB has been shown to reduce perioperative opioid consumption and improve postoperative analgesia in bariatric surgical patients.
Despite the growing use of both techniques, there is limited evidence directly comparing PGNB and ESPB in patients undergoing laparoscopic sleeve gastrectomy. Therefore, the optimal regional analgesic technique for this patient population remains uncertain.
The present study is designed as a prospective, randomized, controlled, parallel-group clinical trial conducted at Atlas University Faculty of Medicine Hospital. Following Institutional Review Board approval and written informed consent, 72 adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. Eligible participants will be between 18 and 65 years of age, classified as ASA physical status II-III, and meet established bariatric surgery criteria.
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups:
- Paragastric Nerve Block (PGNB) Group: Patients will receive intraoperative paragastric nerve block performed by the operating surgeon using 18 mL of 0.5% bupivacaine distributed across predefined paragastric anatomical regions.
- Erector Spinae Plane Block (ESPB) Group: Patients will receive bilateral ultrasound-guided ESPB at the T6 vertebral level before surgery using 0.25% bupivacaine, with a maximum dose not exceeding 2 mg/kg.
- Control Group: Patients will receive standard perioperative multimodal analgesia without regional block intervention.
All participants will undergo standardized general anesthesia and multimodal analgesia protocols. Intraoperative remifentanil administration will be titrated according to routine clinical practice.
The primary outcome measure will be postoperative pain intensity assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery.
Secondary outcome measures will include:
- Total postoperative analgesic and opioid consumption during the first 24 hours.
- Additional analgesic requirements.
- Time to first analgesic request.
- Intraoperative remifentanil consumption.
- Incidence of postoperative nausea and vomiting.
- Block-related adverse events and complications, including local anesthetic systemic toxicity, hematoma, or infection.
Postoperative assessments will be performed by investigators blinded to group allocation whenever feasible. Data will be collected during the intraoperative period, post-anesthesia care unit stay, and throughout the first 24 postoperative hours.
The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of PGNB and ESPB for postoperative pain management following laparoscopic sleeve gastrectomy and may contribute to the optimization of perioperative analgesic strategies in bariatric surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ergun Gunduz, M.D., Assistant Professor
- Phone Number: +905327448021
- Email: ergun.gunduz@atlas.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: - Age between 18 and 65 years Scheduled for elective Sleeve Gastrectomy surgery Classified as ASA physical status II-III Body mass index (BMI) ≥30 kg/m² with obesity-related comorbidities or BMI ≥40 kg/m² Willing to participate in the study and has provided written informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to local anesthetic agents Allergy or contraindication to paracetamol or NSAIDs Coagulopathy or current anticoagulant therapy Infection or skin lesions at the site of block application Chronic pain syndrome Chronic opioid use, opioid dependence, or use of gabapentin/pregabalin Previous upper gastrointestinal surgery Moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²) Moderate to severe liver disease (Child-Pugh B-C or active hepatic disease) Planned additional surgical procedures Inability to assess pain using VAS Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Paragastric Nerve Block (PGNB)
Participants will receive an intraoperative paragastric nerve block performed by the surgeon using 18 mL of 0.5% bupivacaine administered to predefined paragastric anatomical regions in addition to standard general anesthesia and multimodal analgesia.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
|
Experimental: Erector Spinae Plane Block (ESPB)
Participants will receive bilateral ultrasound-guided erector spinae plane block at the T6 vertebral level before surgery in addition to standard general anesthesia and multimodal analgesia.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
|
Active Comparator: No Intervention
Participants will receive standard perioperative multimodal analgesia without regional anesthesia.
Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol.
|
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine.
The total dose will not exceed 2 mg/kg.
The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques.
Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome
Time Frame: Postoperative Hours 1, 6, 12, and 24
|
The primary outcome of this study is the assessment of postoperative pain levels.
Pain intensity will be measured using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at the 1st, 6th, 12th, and 24th postoperative hours.
The effectiveness of the analgesic techniques will be evaluated by comparing VAS scores between the groups.
|
Postoperative Hours 1, 6, 12, and 24
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ul Huda A, Alshahrani AS, Yasir M, Sawilah A, Alharthi AAN. Erector spinae block reduces intraoperative and postoperative opioid consumption in patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled trial. Qatar Med J. 2024 Dec 26;2024(4):58. doi: 10.5339/qmj.2024.58. eCollection 2024.
- Katar MK, Turan UF. Efficacy and Safety of Paragastric Neural Blockade in Controlling Pain, Nausea, and Vomiting After Sleeve Gastrectomy: A Randomized Controlled Trial. Obes Surg. 2024 Jul;34(7):2383-2390. doi: 10.1007/s11695-024-07255-9. Epub 2024 May 7.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ATLAS -PGB-ESP-2026-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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