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

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.

Study Overview

• Status: Recruiting
• Conditions: TAP Block
• Intervention / Treatment: Procedure: Preoperative TAP Block; Procedure: Postoperative TAP block

Detailed Description

The TAP block is a safe, easy-to-perform, and effective technique for managing postoperative pain. It reduces opioid consumption and increases patient satisfaction. Despite recent studies indicating that postoperative TAP block might be more effective than preoperative TAP block in reducing opioid use within 24 hours, the optimal timing of its administration (before or after surgery) remains unclear.

In this study we will compare preoperative to postoperative TAP block in patients undergoing laparoscopic cholecistectomy.

The primary aim of this study is to determine the difference in postoperative pain control between preoperative and postoperative TAP block administration in patients undergoing laparoscopic cholecystectomy.

The primary objective will be to evaluate the difference in postoperative pain at rest, 24 hours after surgery, between patients receiving preoperative versus postoperative TAP block. Pain will be assessed using the Numeric Rating Scale (NRS) from 0 to 10.

Secondary objectives will be intraoperative and postoperative opioids, postoperative nausea and vomiting, pain at resnt and on movement at 0,6,12,24 hours.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia De Pinto, MD; Phone Number: +390496739; Email: silvia.depinto@aopd.veneto.it

Study Locations

• Italy
  • Padua, Italy, 35127
    • Recruiting
    • University Hospital of Padua
    • Contact: Silvia De Pinto; Phone Number: +390498216739; Email: silvia.depinto@aopd.veneto.it
    • Sub-Investigator: Silvia De Pinto, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative TAP block; 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; Patients will receive preoperative TAP block
Active Comparator: Postoperative TAP block; 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; Patients will receive postoperative TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported pain on movement (cough) at the end of the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the end of the surgery.
Patient reported pain on rest at the end of the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the end of the surgery.
Patient reported pain on rest at 6 hours after the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the 6th hour after the end of the surgery.
Patient reported pain on movement at 6 hours after the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the 6th hour after the end of the surgery.
Patient reported pain on rest at 12 hours after the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the 12th hour after the end of the surgery.
Patient reported pain on movement at 12 hours after the surgery	Pain will be assessed with the 11 points NRS scale (0-10)	At the 12th hour after the end of the surgery.
Patient reported pain on rest 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.
Difference in intraoperative opioids	Difference in intraoperative fentanest in micrograms	From the enrollment to the extubation
Difference in postoperative opioids	Difference in postoperative morphine in milligrams	From the extubation to the 24th postoperative hours
Number of participants experiencing postoperative nausea and vomiting	Patients will be asked to report nausea and or vomiting in the postoperative period	From extubation to the 24th postoperative hour

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: TAP block; laparoscopic cholecistectomy
• Other Study ID Numbers: 6126/AO/24

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
• product manufactured in and exported from the U.S.: No