Postoperative Analgesic Efficacy of Recto Intercostal Nerve Block

NCT07003698 | Completed

• 1 other identifier: AEŞH-EK-2025-009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Recto Intercostal Nerve Block; Laparoskopic Cholecystectomy

Keywords

Remifantanile conception; Acute pain; Postoperatif pain

Outcome Measures

Primary Outcomes (1)

• Intraoperative remifentanil consumption

  The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded

  During the intraoperative period

Secondary Outcomes (1)

• Pain scores

  First 24 hours after surgery

Study Arms (2)

The group without rectointercostal nerve block

ACTIVE COMPARATOR

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.

Procedure: The group without the rectointercostal nerve block

Postoperative analgesic efficacy of rectointercostal nerve block

ACTIVE COMPARATOR

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.

Procedure: The rectointercostal plane block

Interventions

The group without the rectointercostal nerve block 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.

The group without rectointercostal nerve block

The rectointercostal plane block 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.

Postoperative analgesic efficacy of rectointercostal nerve block

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: June 4, 2025
• Study Start: June 22, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 28, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TU (1)