Rectus Sheath Block as an Adjunct to General Anesthesia for Midline Laparotomy Pain

NCT07393763 | Completed

• 2 other identifiers: 2022.02.1.0341EC-UNUD-82.0-2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB with local anesthetic (bupivacaine 0.25%). After surgery, pain will be assessed using the Numeric Rating Scale (NRS) at 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. The study will also compare the time to first opioid request, total opioid use during the first 24 hours after surgery, and changes in inflammation measured by the neutrophil-to-lymphocyte ratio (NLR). The goal is to determine whether RSB can reduce postoperative pain and opioid requirements and help limit postoperative inflammatory response.

Conditions

Postoperative Pain; Abdominal Surgery by Laparotomy

Keywords

Rectus Sheath Block; Midline Laparotomy; Ultrasound-Guided; Opioid Consumption; Numeric Rating Scale; Neutrophil-to-Lymphocyte Ratio; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity (Numeric Rating Scale, NRS)

  Pain intensity measured using the Numeric Rating Scale (0-10; 0 = no pain, 10 = worst imaginable pain) by a blinded assessor.

  15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery

Secondary Outcomes (4)

• Time to First Opioid Request

  Up to 24 hours after surgery

• Total Opioid Consumption

  24 hours after surgery

• Change in Neutrophil-to-Lymphocyte Ratio (NLR)

  Preoperative (1 day before surgery) and postoperative (in recovery room)

• Postoperative Nausea and Vomiting (PONV

  Up to 24 hours after surgery

Study Arms (2)

Control: General Anesthesia Only

NO INTERVENTION

Participants receive standard general anesthesia without rectus sheath block. Postoperative analgesia follows institutional protocol (e.g., PCA morphine and paracetamol).

Intervention: General Anesthesia + Bilateral Rectus Sheath Block

EXPERIMENTAL

Participants receive standard general anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (single-shot) using bupivacaine 0.25%, 20 mL per side, performed after induction of anesthesia.

Procedure: Ultrasound-guided rectus sheath block

Interventions

Ultrasound-guided rectus sheath block PROCEDURE

Bilateral posterior rectus sheath block performed under ultrasound guidance after induction of general anesthesia. Single-shot injection of bupivacaine 0.25% (20 mL per side) between the rectus abdominis muscle and posterior rectus sheath.

Intervention: General Anesthesia + Bilateral Rectus Sheath Block

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-64 years.
• Patients undergoing midline laparotomy incision (incision extending above to below the umbilicus) for digestive, obstetric, or oncology cases (corresponding to T7-T12 dermatomes) under general anesthesia.
• ASA physical status I-III.
• Body mass index (BMI) 18.5-30 kg/m².
• Willing and able to provide written informed consent.

You may not qualify if:

• Refusal to participate.
• Infection or wound at the planned block site.
• Decreased level of consciousness.
• Known allergy to local anesthetics or opioids.
• Coagulation disorder.
• History of chronic pain.
• Hyperalgesia.

Sponsors & Collaborators

• Udayana University: lead
• RS Prof. Dr. I.G.N.G Ngoerah: collaborator

Study Sites (1)

Ngoerah Hospital, Denpasar, Bali, Indonesia

Denpasar, Bali, 80111, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• I Made Prema Putra

  Udayana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded to group assignment. Postoperative pain assessments (NRS) and outcome data collection were performed by an independent assessor who was blinded to allocation. Randomization codes were kept in sealed envelopes and were not disclosed to the assessor until data collection was completed. Data analysis was performed using coded group labels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel-group randomized trial comparing general anesthesia alone versus general anesthesia plus bilateral ultrasound-guided rectus sheath block.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)