Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy

NCT ID: NCT07193472

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2025-12-31

Brief Summary

Most patients undergoing laparoscopic cholecystectomy (LC) experience moderate to severe pain in the first 24 hours after surgery. Port infiltration is the usual analgesic method while serratus-intercostal plane blockade (SIPB) has shown its efficacy in open cholecystectomy pain control. The aim of the present study was to compare the efficacy of both techniques in pain control.

OBJECTIVE The prospective randomised study has the working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery and pain control.

Secondary objectives of the study will be to assess the absence of adverse effects.

MATERIAL AND METHODS the investigators present a low-intervention clinical trial. The sample will be composed of 128 patients divided into two groups according to the analgesic technique (serratus-intercostal and port infiltration), following a 1:1 randomisation, consecutively until the sample size is reached and fulfilling the following criteria: signature of informed consent, over 18 years of age, ASA I-III, undergoing laparoscopic cholecystectomy.

Intraoperatively, patients will receive standard monitoring and induction. Analgesia will consist of a multimodal strategy (8 mg dexamethasone, 1 g paracetamol and 50 mg dexketoprofen pre-incisionally, intraoperative fentanyl on demand and the corresponding regional technique).

In the postoperative period, the main variable to be evaluated in forms designed for this purpose will be the difference in pain assessed by means of an numeric rating scale (NRS scale) and the quality of recovery will be measured by means of the modified Postoperative Quality of Recovery Score (QoR-15 ) recovery scale (15 responses).

Detailed Description

Background

Postoperative pain remains a significant concern following laparoscopic cholecystectomy (LC), with most patients experiencing moderate to severe pain within the first 24 hours. Traditionally, port-site infiltration (PI) with local anesthetics is employed for analgesia. However, the serratus-intercostal plane block (SIPB), also known as the modified BRILMA block, has demonstrated efficacy in pain management for open cholecystectomy. Its role in LC remains to be clarified.

Objective

The primary objective of this prospective randomised study is to evaluate whether SIPB (modified BRILMA block) provides equivalent or superior postoperative analgesia and quality of recovery compared to port-site infiltration in patients undergoing LC.

Secondary objective: To assess the incidence of adverse effects related to each analgesic technique.

Methods

This study is designed as a low-intervention, prospective, randomized clinical trial. A total of 128 adult patients (ASA I-III) scheduled for elective laparoscopic cholecystectomy will be randomly allocated (1:1) to receive either serratus-intercostal plane block or laparoscopic port infiltration for perioperative analgesia. Randomization will be performed consecutively until the target sample size is reached.

Inclusion Criteria:

Age ≥ 18 years

ASA physical status I-III

Informed consent provided

Exclusion Criteria:

(Coagulopaty, allergy to local anaesthetic, history of chronic pain)

Intraoperative Management:

All patients will receive standardized general anesthesia and multimodal analgesia comprising:

8 mg dexamethasone

1 g paracetamol

50 mg dexketoprofen (administered pre-incisionally)

Fentanyl as needed during surgery

Assigned regional analgesic technique (SIPB or PI)

Postoperative Evaluation:

Primary Outcome Measures:

Pain intensity using the Numerical Rating Scale (NRS) at predefined intervals

Quality of recovery assessed via the modified QoR-15 questionnaire

Secondary Outcome Measure:Incidence of adverse events or complications related to the analgesic techniques

SIPB group: receive The Serratus intercostal plane block as analgesic technique after induction. With the patient lying in supine position, the local anaesthetic is administered in the plane under Serratus muscle at the 8th rib level Infiltration group: in this group the surgeons administered local anaesthetic after inserting the trocar.

Conclusion (anticipated)

This trial aims to determine whether SIPB offers superior analgesic efficacy and recovery quality compared to standard port infiltration in LC, potentially informing improved postoperative pain protocols.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

port infiltration

patients receiving port infiltration as analgesia

Group Type: OTHER

serratus intercostal plane block as analgesic technique

Intervention Type: PROCEDURE

the SIPB will be applied after starting surgery and before general anaesthesia

Interventions

serratus intercostal plane block as analgesic technique

the SIPB will be applied after starting surgery and before general anaesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ASA I-II-III
• laparoscopic cholecystectomy

Exclusion Criteria

• Alergy to used drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Rio Hortega

OTHER

Sponsor Role: lead

Responsible Party

María Teresa Fernandez

MD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Teresa Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Rio Hortega

Locations

Fernandez

Valladolid, Valladolid, Spain

Countries

Spain

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

PI-25- 298-H

Identifier Type: OTHER

Identifier Source: secondary_id

PI-25- 298-H

Identifier Type: -

Identifier Source: org_study_id