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NCT Number: NCT07176299

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

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.

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Key information

Conditions

Cholelithiasis Anesthesia, Local Biliary Tract Diseases Cholecystectomy, Laparoscopic Digestive System Diseases Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital in Olsztyn

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral laparoscopic TAP block (0.25% bupivacaine)

Procedure

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

Local anesthetic infiltration (0.25% bupivacaine)

Procedure

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

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    Rescue analgesic use was recorded for each participant during the first 24 hours after laparoscopic cholecystectomy. Medications included metamizole, paracetamol, and oxycodone, administered according to standardized postoperative pain protocols: metamizole at 6, 12, 18, and 24 hours unless NRS ≤1, paracetamol if NRS >4, and oxycodone if NRS >6. The number and percentage of patients requiring each medication at 6, 12, 18, and 24 hours postoperatively were analyzed.

Sponsors and collaborators

Lead sponsor

University of Warmia and Mazury in Olsztyn

Other

Registry information

Official study title

Efficacy of Unilateral Laparoscopic Transversus Abdominis Plane Block Compared to Local Infiltration in Postoperative Analgesia Following Laparoscopic Cholecystectomy

Acronym: TAP vs LAI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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