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Completed

NCT Number: NCT07393763

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ngoerah Hospital, Denpasar, Bali, Indonesia

Denpasar, Bali, 80111, Indonesia

About this study

This is a double-blind randomized controlled trial conducted in adult patients (18-64 years) undergoing midline incision laparotomy under general anesthesia at Sanglah Hospital. Eligible participants are enrolled consecutively and randomized using permuted block randomization with sealed envelopes into two parallel groups:

Group A (Control): General anesthesia without rectus sheath block.

Group B (Intervention): General anesthesia plus bilateral ultrasound-guided posterior rectus sheath block (RSB) using bupivacaine 0.25%.

Anesthetic management is standardized. Patients receive IV midazolam 0.02 mg/kg as premedication. Induction is performed with propofol 1-2 mg/kg and fentanyl 2 mcg/kg, followed by atracurium 0.5 mg/kg for intubation. Maintenance includes pressure-controlled ventilation (FiO₂ 40%, flow 2 L/min) and propofol infusion 50-150 mcg/kg/min. Intraoperative analgesia is supplemented with fentanyl 0.5 mcg/kg every 45 minutes. Hemodynamics are maintained within 20% of baseline.

RSB technique (Group B): After intubation, the abdominal skin is disinfected. A linear ultrasound probe is placed lateral to the umbilicus to identify the rectus abdominis muscle and posterior rectus sheath. Using an in-plane approach, a 50 mm needle is advanced from lateral to medial until the needle tip lies between the rectus abdominis muscle and posterior rectus sheath. After negative aspiration, 20 mL of bupivacaine 0.25% is injected as a single-shot on one side with aspiration every 3 mL, visualizing separation of the rectus muscle from the posterior sheath. The procedure is then repeated on the contralateral side (bilateral block).

Postoperative management and assessments: Pain is evaluated by an independent observer using the Numeric Rating Scale (NRS 0-10) at T1 (15 minutes in the recovery room), T2 (1 hour), T3 (3 hours), T4 (6 hours), T5 (12 hours), and T6 (24 hours) postoperatively. Postoperative analgesia includes patient-controlled analgesia (PCA) morphine demand-only (1 mg per demand dose) for patients with GCS 15, plus oral paracetamol 500 mg every 6 hours. The time to first opioid request is recorded (minutes), and total morphine consumption during the first 24 hours is collected.

Inflammation assessment: Neutrophil-to-lymphocyte ratio (NLR) is measured from complete blood count (CBC) preoperatively (one day before surgery) and postoperatively (in the recovery room).

Key outcomes include postoperative NRS scores (T1-T6), time to first opioid request, total opioid requirement in the first 24 hours, and perioperative changes in NLR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Postoperative Pain Intensity (Numeric Rating Scale, NRS)

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

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

Secondary outcomes

  1. Time to First Opioid Request

    Time frame: Up to 24 hours after surgery

    Time from arrival in recovery room to first request for opioid analgesia (minutes).

  2. Total Opioid Consumption

    Time frame: 24 hours after surgery

    Total morphine consumption recorded from PCA during the first 24 hours after surgery (mg)

  3. Change in Neutrophil-to-Lymphocyte Ratio (NLR)

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

    NLR calculated from complete blood count measured preoperatively and postoperatively in the recovery room.

  4. Postoperative Nausea and Vomiting (PONV

    Time frame: Up to 24 hours after surgery

    Incidence of nausea/vomiting within 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Collaborators

  • RS Prof. Dr. I.G.N.G Ngoerah

Registry information

Official study title

Effectiveness of Rectus Sheath Block as an Adjunct to General Anesthesia for Postoperative Pain and Inflammation in Patients Undergoing Midline Incision Laparotomy at RSUP Sanglah

Acronym: RSB-MIDLINE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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