Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration

May 6, 2026 updated by: Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital

Comparison of the Analgesic Effects of Local Anesthetic Infiltration and Ultrasound-Guided Rectus Sheath Block in Laparoscopic Cholecystectomy Operations: A Prospective Randomized Controlled Study

Laparoscopic cholecystectomy is associated with significant postoperative pain originating from trocar sites, pneumoperitoneum, and visceral irritation. Both local anesthetic infiltration and ultrasound-guided rectus sheath block are commonly used regional analgesic techniques to reduce postoperative pain and opioid consumption. This prospective randomized controlled study aims to compare the effects of these two techniques on postoperative pain scores, opioid requirements, and analgesia-related adverse effects following laparoscopic cholecystectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic cholecystectomy is a very commonly performed and painful surgical procedure. The etiology of pain is complex and commonly includes pain related to trocar insertion sites, pain secondary to carbon dioxide insufflation, visceral pain, and shoulder pain. Various analgesic medications and regional anesthesia techniques are used for postoperative pain management. Abdominal wall blocks are frequently utilized to reduce opioid-related adverse effects.

Rectus sheath block is a regional anesthesia technique that blocks the anterior cutaneous branches of the lower thoracic nerves (T7-T12) and is used for analgesia in laparoscopic surgeries. Several studies have demonstrated that local anesthetic infiltration provides effective analgesia in laparoscopic cholecystectomy. Although rectus sheath block is an old technique traditionally used in midline surgeries, its analgesic use in laparoscopic procedures has increased in recent years.

In this prospective randomized clinical trial, we aimed to compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.

To compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) class I-II patients
  • Patients aged between 18 and 65 years
  • Patients undergoing laparoscopic cholecystectomy surgery

Exclusion Criteria:

  • ASA class III-IV patients
  • Patients undergoing emergency surgery
  • Relatives of patients who do not provide consent
  • Presence of chronic pain
  • Chronic opioid use
  • Presence of local anesthetic allergy
  • Ibuprofen allergy
  • Paracetamol allergy
  • Presence of infection at the block site
  • Coagulopathy
  • Increased intracranial pressure
  • Pre-existing neurological deficit
  • Severe organ failure
  • Mental retardation
  • Anatomical deformity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP RSB

Rectus Sheath Block:

After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration.
Procedure: Rectus Sheath Block
After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the rectus muscle and posterior sheath and confirmation of appropriate spread, 20 mL local anesthetic (0.25% bupivacaine) will be administered with intermittent negative aspiration.
Active Comparator: GROUP LAI

Local Anesthetic Infiltration:

At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.
Procedure: Local Anesthetic Infiltration
At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Score
Time Frame: Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.
Postoperative pain assessment will be performed using the Numeric Rating Scale (NRS). The NRS is a scale in which patients rate their pain intensity numerically from 0 (no pain) to 10 (worst imaginable pain).
Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 24 hour
Postoperative opioid consumption will be evaluated using intravenous patient-controlled analgesia (IV PCA) over 24 hours. PCA will be set in bolus-only mode (10 mg tramadol), without continuous infusion. Patients will be educated preoperatively regarding PCA use and instructed to administer boluses in case of pain. At the end of 24 hours, total opioid consumption will be recorded from the device data, and the time to first bolus administration (time to first analgesic requirement) will also be evaluated.
24 hour
Adverse Effects
Time Frame: 24 hour
Adverse effects such as hypotension, bradycardia, nausea, vomiting, and local anesthetic systemic toxicity (LAST) occurring within the first 24 postoperative hours will be monitored and recorded.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Principal Investigator: LEYLA KILINC, şişli etfal eğitim araştırma hastanesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 12, 2026

Primary Completion (Estimated)

November 12, 2026

Study Completion (Estimated)

December 12, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zeynep-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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