Unilateral Laparoscopic TAP Block vs. Local Infiltration in Post-Cholecystectomy Analgesia

NCT07176299 | Completed

• 1 other identifier: University of Warmia and Mazur
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.

Conditions

Cholelithiasis; Cholecystectomy, Laparoscopic; Pain, Postoperative; Anesthesia, Local; Nerve Block

Keywords

Laparoscopic cholecystectomy; unilateral transversus abdominis plane block; local anesthetic infiltration; postoperative pain management; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy

  Pain intensity was assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Scores were recorded by patients at rest at three time points after laparoscopic cholecystectomy: 2 hours, 6 hours, and 24 hours postoperatively. Pain was evaluated as an overall score and at specific surgical sites (umbilical, subcostal, and substernal wounds). Assessments were performed only when patients reached an adequate level of consciousness, verified by Aldrete score.

  Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day.

Secondary Outcomes (1)

• Use of rescue analgesics (metamizole, paracetamol, oxycodone) within 24 hours after laparoscopic cholecystectomy

  Rescue analgesic use assessed at 6, 12, 18, and 24 hours after surgery during the first postoperative day.

Study Arms (4)

TAP Block

EXPERIMENTAL

Participants received a unilateral laparoscopic transversus abdominis plane (TAP) block performed under direct laparoscopic vision using 20 mL of 0.25% bupivacaine.

Procedure: Unilateral laparoscopic TAP block (0.25% bupivacaine)

Local Anesthetic Infiltration (LAI)

ACTIVE COMPARATOR

Participants received local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites under laparoscopic guidance.

Procedure: Local anesthetic infiltration (0.25% bupivacaine)

TAP + LAI

EXPERIMENTAL

Participants received a combination of unilateral laparoscopic TAP block (10 mL of 0.25% bupivacaine) and local anesthetic infiltration at trocar sites (10 mL of 0.25% bupivacaine).

Procedure: Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)

Control (No Regional Anesthesia)

NO INTERVENTION

Participants did not receive regional anesthesia. Postoperative pain management was provided only with standardized intravenous analgesics.

Interventions

Unilateral laparoscopic TAP block (0.25% bupivacaine) PROCEDURE

Injection of 20 mL 0.25% bupivacaine into the transversus abdominis plane under direct laparoscopic vision.

TAP Block

Local anesthetic infiltration (0.25% bupivacaine) PROCEDURE

Injection of 20 mL 0.25% bupivacaine distributed across trocar insertion sites under laparoscopic guidance.

Local Anesthetic Infiltration (LAI)

Combined TAP block and local anesthetic infiltration (0.25% bupivacaine) PROCEDURE

10 mL of 0.25% bupivacaine given as a TAP block and 10 mL administered as local infiltration at trocar sites.

TAP + LAI

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 to 85 years
• Scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis confirmed by ultrasonography
• American Society of Anesthesiologists (ASA) physical status I-II
• Provided written informed consent

You may not qualify if:

• ASA physical status III-IV
• Contraindications to laparoscopy
• Acute cholecystitis diagnosed preoperatively or perioperatively
• Chronic analgesic use
• Spinal degenerative joint disease
• Known allergy to local anesthetics
• Opioid or alcohol dependence
• Psychiatric or neurological disorders
• Lack of consent or withdrawal of consent

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Study Sites (1)

University Clinical Hospital in Olsztyn

Olsztyn, Warmian-Masurian Voivodeship, 11-041, Poland

Location

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were blinded to group allocation. The statistician analyzing the results was also blinded. Care providers performing the procedures were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: 1. unilateral laparoscopic TAP block, 2. local anesthetic infiltration (LAI), 3. combined TAP+LAI, 4. control (no regional anesthesia). Each participant remained in the assigned group throughout the study.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: September 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)