Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy

NCT07811206 | Not Yet Recruiting

• 1 other identifier: ATLAS -PGB-ESP-2026-1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity Postoperative Pain; Obesity Morbid Obesity Postoperative Pain

Keywords

Sleeve Gastrectomy, Bariatric Surgery, Paragastric Nerve Block, Erector Spinae Plane Block,Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia,

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  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

Study Arms (3)

Paragastric Nerve Block (PGNB)

EXPERIMENTAL

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.

Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

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.

Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator

No Intervention

ACTIVE COMPARATOR

Participants will receive standard perioperative multimodal analgesia without regional anesthesia. Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol.

Procedure: Paragastric Nerve Block (PGNB); Procedure: ESPB; Procedure: Active Comparator

Interventions

Paragastric Nerve Block (PGNB) PROCEDURE

Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.

Erector Spinae Plane Block (ESPB); No Intervention; Paragastric Nerve Block (PGNB)

ESPB PROCEDURE

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.

Erector Spinae Plane Block (ESPB); No Intervention; Paragastric Nerve Block (PGNB)

Active Comparator PROCEDURE

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.

Erector Spinae Plane Block (ESPB); No Intervention; Paragastric Nerve Block (PGNB)

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Related Publications (2)

• 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.

  PMID: 39944209 RESULT

• 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.

  PMID: 38713336 RESULT

Related Links

• Related Info
• Related Info

Central Study Contacts

Ergun Gunduz, M.D., Assistant Professor

CONTACT

+905327448021; ergun.gunduz@atlas.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for postoperative data collection will be blinded to treatment allocation. Due to the nature of the intervention, the anesthesiologist performing the block and the participants cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible patients undergoing elective laparoscopic sleeve gastrectomy will be randomized in a 1:1:1 ratio to one of three parallel groups: Paragastric Nerve Block (PGNB), Erector Spinae Plane Block (ESPB), or standard analgesia (control group). Participants will remain in their assigned treatment group throughout the study, and outcomes will be compared between groups during the first 24 postoperative hours.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share