Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration

NCT07582029 | Not Yet Recruiting

• 1 other identifier: zeynep-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiases; Cholecystitis; Postoperative Pain

Keywords

Cholecystectomy, Laparoscopic; Rectus Sheath Block; Anesthesia, Local; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• NRS Score

  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 Outcomes (2)

• Opioid Consumption

  24 hour

• Adverse Effects

  24 hour

Study Arms (2)

GROUP RSB

ACTIVE COMPARATOR

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

GROUP LAI

ACTIVE COMPARATOR

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

Interventions

Local Anesthetic Infiltration PROCEDURE

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.

GROUP LAI

Rectus Sheath Block PROCEDURE

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.

GROUP RSB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• LEYLA KILINC

  şişli etfal eğitim araştırma hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LEYLA KILINC

CONTACT

+90 532 417 02 44; leylaturkoglu@hotmail.com

MUSTAFA ALTINAY

CONTACT

05333914422; m_altinay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

TU (1)