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

NCT ID: NCT07176299

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2023-06-30

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.

Detailed Description

Gallbladder stones are a common condition, and laparoscopic cholecystectomy is the standard treatment. Effective pain control after surgery is important for recovery and patient comfort. Traditionally, local anesthetic infiltration (LAI) at the surgical wound sites is used. Another method, the transversus abdominis plane (TAP) block, may provide better pain relief.

This prospective, randomized clinical trial was conducted at the University Clinical Hospital in Olsztyn, Poland. A total of 160 patients undergoing elective laparoscopic cholecystectomy were randomized into four groups: TAP block, LAI, TAP+LAI, and control. All patients received the same type of anesthesia and standard pain medications.

The primary goal was to compare pain intensity within 24 hours after surgery using the Numerical Rating Scale (NRS). Secondary measures included use of additional painkillers, recovery scores (Aldrete), and possible complications at the wound site. The influence of surgical drains and gallstone size on pain was also examined.

The study found that the unilateral laparoscopic TAP block provided the best pain relief, fewer wound-related complications, and reduced need for additional medications compared with other methods. These results suggest that the laparoscopic TAP block is a safe and effective option for improving postoperative pain management after gallbladder surgery.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAP Block

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

Group Type: EXPERIMENTAL

Unilateral laparoscopic TAP block (0.25% bupivacaine)

Intervention Type: PROCEDURE

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

Local Anesthetic Infiltration (LAI)

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

Group Type: ACTIVE_COMPARATOR

Local anesthetic infiltration (0.25% bupivacaine)

Intervention Type: PROCEDURE

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

TAP + LAI

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).

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Control (No Regional Anesthesia)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Unilateral laparoscopic TAP block (0.25% bupivacaine)

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

Intervention Type: PROCEDURE

Local anesthetic infiltration (0.25% bupivacaine)

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

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Warmia and Mazury in Olsztyn

OTHER

Sponsor Role: lead

Responsible Party

Łukasz Dyśko

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinical Hospital in Olsztyn

Olsztyn, Warmian-Masurian Voivodeship, Poland

Countries

Poland

Other Identifiers

University of Warmia and Mazur

Identifier Type: -

Identifier Source: org_study_id