Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy

NCT07193472 | Active Not Recruiting DMC

• 1 other identifier: PI-25- 298-H
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• side efects

  one year

• Postoperative pain control

  One year

• Postoperative recovery

  One year

Study Arms (1)

port infiltration

OTHER

patients receiving port infiltration as analgesia

Procedure: serratus intercostal plane block as analgesic technique

Interventions

serratus intercostal plane block as analgesic technique PROCEDURE

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

port infiltration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II-III
• laparoscopic cholecystectomy

You may not qualify if:

• Alergy to used drugs

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Fernandez

Valladolid, Valladolid, 47008, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Maria Teresa Fernandez, MD

  Hospital del Rio Hortega

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: both groups are masked about the receiving analgesia
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: September 25, 2025
• Study Start: June 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)