Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy

Analgesic Efficacy of Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy: Randomised Clinical Trial

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: serratus intercostal plane block as analgesic technique

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid
    • Valladolid, Valladolid, Spain, 47008
      • Fernandez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-II-III
• laparoscopic cholecystectomy

Exclusion Criteria:

• Alergy to used drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: port infiltration; patients receiving port infiltration as analgesia	Procedure: serratus intercostal plane block as analgesic technique; the SIPB will be applied after starting surgery and before general anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efectiveness of analgesia (SIPB versus IP)	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 (QoR15) and pain control (NRS) 0-10	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side efects	assesment of side efects	one year
Postoperative pain control	Pain developed for patients after surgery first 24 h . nRS 0-10	One year
Postoperative recovery	Intake, rest at night, walking…assessed with QoR15 0- 150	One year

Collaborators and Investigators

• Sponsor: Hospital del Rio Hortega
• Investigators: Principal Investigator: Maria Teresa Fernandez, MD, Hospital del Rio Hortega

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Estimated): September 25, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: PI-25- 298-H (Other Identifier: RIO HORTEGA UNIVERSITY HOSPITAL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No