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

U

University of Warmia and Mazury in Olsztyn

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07176299
University of Warmia and Mazur

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 4 patient groups

TAP Block
Experimental group
Description:
Participants received a unilateral laparoscopic transversus abdominis plane (TAP) block performed under direct laparoscopic vision using 20 mL of 0.25% bupivacaine.
Treatment:
Procedure: Unilateral laparoscopic TAP block (0.25% bupivacaine)
Local Anesthetic Infiltration (LAI)
Active Comparator group
Description:
Participants received local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites under laparoscopic guidance.
Treatment:
Procedure: Local anesthetic infiltration (0.25% bupivacaine)
TAP + LAI
Experimental group
Description:
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).
Treatment:
Procedure: Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)
Control (No Regional Anesthesia)
No Intervention group
Description:
Participants did not receive regional anesthesia. Postoperative pain management was provided only with standardized intravenous analgesics.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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