NCT07576712

Brief Summary

This non-randomized controlled study evaluated the efficacy of a right-sided unilateral Transversus Abdominis Plane (TAP) block for postoperative pain management in 60 adult patients undergoing elective laparoscopic cholecystectomy. Participants were equally divided into a control group receiving standard care and an intervention group that received an ultrasound-guided TAP block using 0.25% bupivacaine prior to extubation. While all patients received scheduled paracetamol and dexketoprofen, tramadol was administered as a rescue analgesic for resting pain scores of 5 or higher. The study's primary goal was to compare postoperative pain using the Verbal Numerical Rating Scale (VNRS) at 0, 6, 12, and 24 hours, with secondary outcomes tracking total rescue tramadol consumption, surgical variables, and postoperative complications to determine the TAP block's overall clinical benefit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain scale measurements

    Verbal Numerical Rating Scale (from 0-10) for pain

    24 hours

Study Arms (2)

TAP Block Group

Patients with TAP block

Other: TAP Block

Control Group

Patients without TAP block

Interventions

The TAP block was performed during the post-anesthesia phase before extubation. The procedure involved the use of an ultrasound system and a linear ultrasound transducer. To perform the TAP block, the linear probe was positioned 2 cm below the xiphoid to locate the rectus abdominis muscle and fascia. Moving the probe in a downward and lateral direction, the external oblique, internal oblique, and transversus abdominis muscles and fascia were identified over the oblique subcostal angle. A 1-2 ml dose of 2% lidocaine was then applied at the insertion site of the peripheral block needle. With the probe in the oblique subcostal position, the peripheral block needle was carefully advanced along the fascia of the transversus abdominis and internal oblique muscles, from the medial to the inferolateral area of the probe.

TAP Block Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have cholelithiasis

You may qualify if:

  • individuals aged 18 years or older, scheduled for elective laparoscopic cholecystectomy to treat cholelithiasis, American Society of Anesthesiologists (ASA) physical status of I or II, with no communication barriers, able to cooperate during the intervention, and understanding the use of relevant assessment scales

You may not qualify if:

  • individuals with contraindications to nerve block, such as infection at the puncture site; those diagnosed with malignancy; individuals suffering from severe liver and kidney diseases, coagulation dysfunction, or similar conditions; individuals with a history of previous abdominal surgery or trauma; long-term users of sedative and analgesic drugs, or those with addiction to alcohol, sedatives, or analgesics; individuals experiencing chronic pain; those with known allergies to the drugs used in the study; individuals with mental illnesses that interfere with perception and pain assessment; individuals taking analgesics prior to surgery; individuals with a body mass index (BMI) ≥ 35; patients who were converted from laparoscopic surgery to open surgery; perforation of the gallbladder during cholecystectomy; women who are pregnant or breastfeeding, and patients who withdrew their consent at any stage of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • Grape S, Kirkham KR, Akiki L, Albrecht E. Transversus abdominis plane block versus local anesthetic wound infiltration for optimal analgesia after laparoscopic cholecystectomy: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth. 2021 Dec;75:110450. doi: 10.1016/j.jclinane.2021.110450. Epub 2021 Jul 6.

    PMID: 34243030BACKGROUND
  • Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.

    PMID: 34422893BACKGROUND
  • Karasu D, Yilmaz C, Ozgunay SE, Yalcin D, Ozkaya G. Ultrasound-guided transversus abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy: A retrospective study. North Clin Istanb. 2020 Nov 24;8(1):88-94. doi: 10.14744/nci.2020.84665. eCollection 2021.

    PMID: 33623879BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 8, 2026

Study Start

May 15, 2023

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations