Postoperative Analgesic Efficacy of Recto Intercostal Nerve Block

NCT ID: NCT07003698

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-22
• Study Completion Date: 2025-12-21

Brief Summary

Laparoscopic cholecystectomy is a frequently performed surgery and the gold standard for the treatment of symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain impairs recovery quality and increases the risk of postoperative pulmonary complications, serving as a risk factor for chronic pain development.

Multimodal analgesia, including opioids, is used to manage pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.

The primary aim of this study is to evaluate the effect of recto-intercostal nerve block as part of multimodal analgesia on intraoperative opioid consumption and postoperative pain scores in patients undergoing laparoscopic cholecystectomy.

Conditions

Laparoskopic Cholecystectomy; Recto Intercostal Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The group without rectointercostal nerve block

Patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block.

Group Type: ACTIVE_COMPARATOR

The group without the rectointercostal nerve block

Intervention Type: PROCEDURE

Patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block.

Postoperative analgesic efficacy of rectointercostal nerve block

The patient lies in the supine position. The skin is disinfected. A high-frequency linear probe (6-13 MHz) is placed lateral to the xiphoid to visualize the rectus abdominis muscle at the level of the 7th rib. Using an in-plane technique, a 22G, 80 mm block needle is inserted in a cranial direction into the interfascial plane immediately inferolateral to the xiphoid, between the rectus abdominis muscle and the 6th-7th costal cartilages. A total of 20 ml of local anesthetic solution is injected bilaterally (40 ml of 0.25% bupivacaine (marcaine)). The spread of the local anesthetic is confirmed by ultrasound guidance.

Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period.

Group Type: ACTIVE_COMPARATOR

The rectointercostal plane block

Intervention Type: PROCEDURE

The rectointercostal plane block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position. Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period.

Interventions

The group without the rectointercostal nerve block

Patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period. These patients will not receive the rectointercostal nerve block.

Intervention Type: PROCEDURE

The rectointercostal plane block

The rectointercostal plane block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position. Additionally, patients in this group will be administered dexketoprofen 50 mg and tramadol 100 mg intravenously in the intraoperative period.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years old
• American Society of Anesthesiologists (ASA) physical status I-II-III
• Elective laparoscopic cholecystectomy surgery

Exclusion Criteria

• Under 18 and over 65 years old
• ASA score IV and above
• Advanced co-morbidity
• History of bleeding diathesis
• Patient refusing the procedure
• Chronic opioid or analgesic use
• Patients who will operate under emergency conditions
• Block injection site infection
• Known allergy to local anesthetics
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muruvvet Taskir Turan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

MÜRÜVVET TAŞKIR TURAN, MD

Role: CONTACT

taskirmuruvvet@gmail.com

00905065536934

MUSA ZENGİN, Associate Professor

Role: CONTACT

musazengin@gmail.com

00905307716235

Facility Contacts

MÜRÜVVET TAŞKIR TURAN, MD

Role: primary

taskirmuruvvet@gmail.com

00905065536934

MUSA ZENGİN, Associate Professor

Role: backup

musazengin@gmail.com

00905307716235

Other Identifiers

AEŞH-EK-2025-009

Identifier Type: -

Identifier Source: org_study_id