Preoperative TAP Block Versus Postoperative TAP Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

NCT06903182 | Recruiting

• 1 other identifier: 6126/AO/24
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the regional anesthesia technique "TAP block" provide more analgesia when performed before or after the surgery. The main questions it aims to answer are: Does preoperative TAP block provide greater analgesia than postoperative TAP block? Patients receiving preoperative TAP block will have less pain and take less painkillers than patients receiving postoperative TAP block? Participants will: Receive preoperative or postoperative TAP block They will be asked about their pain levels during the hospital stay.

Conditions

TAP Block

Keywords

TAP block; laparoscopic cholecistectomy

Outcome Measures

Primary Outcomes (1)

• Patient reported pain on movement at 24 hours after the surgery

  Pain will be assessed with the 11 points NRS scale (0-10)

  At the 24th hour after the end of the surgery.

Secondary Outcomes (10)

• Patient reported pain on movement (cough) at the end of the surgery

  At the end of the surgery.

• Patient reported pain on rest at the end of the surgery

  At the end of the surgery.

• Patient reported pain on rest at 6 hours after the surgery

  At the 6th hour after the end of the surgery.

• Patient reported pain on movement at 6 hours after the surgery

  At the 6th hour after the end of the surgery.

• Patient reported pain on rest at 12 hours after the surgery

  At the 12th hour after the end of the surgery.

Study Arms (2)

Preoperative TAP block

EXPERIMENTAL

Patients will receive a preoperative TAP block with 40 mL (20 mL on the right side + 20 mL on the left side) of Ropivacaine 0.4%

Procedure: Preoperative TAP Block

Postoperative TAP block

ACTIVE COMPARATOR

Patients will receive a postoperative TAP block with 40 mL (20 mL on the right side + 20 mL on the left side) of Ropivacaine 0.4%

Procedure: Postoperative TAP block

Interventions

Preoperative TAP Block PROCEDURE

Patients will receive preoperative TAP block

Preoperative TAP block

Postoperative TAP block PROCEDURE

Patients will receive postoperative TAP block

Postoperative TAP block

Eligibility Criteria

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

You may qualify if:

• ASA I-II patients
• Age \>18 years
• Informed consent

You may not qualify if:

• History of chronic pain
• Beta-blocker therapy
• Allergy to the drugs used in the study

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padua

Padua, Italy, 35127, Italy

RECRUITING

Central Study Contacts

Silvia De Pinto, MD

CONTACT

+390496739; silvia.depinto@aopd.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be masked as the intervention (TAP block) will be performed after induction of general anesthesia Outcome assessor will be unaware of the group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: June 16, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)