NCT07849751

Brief Summary

This randomized controlled trial compared laparoscopic-assisted transversus abdominis plane (TAP) block with trocar-site local anesthetic infiltration for postoperative pain management in adult patients undergoing laparoscopic appendectomy for uncomplicated acute appendicitis. Sixty patients were randomized to receive either bilateral laparoscopic-assisted TAP block or local anesthetic infiltration at the trocar sites. Postoperative pain intensity, rescue analgesic requirements, recovery parameters, postoperative nausea and vomiting, complications, and length of hospital stay were evaluated.

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 not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2018

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Postoperative PainTransversus Abdominis Plane BlockTAP BlockLaparoscopic AppendectomyBupivacaine

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS)

    Postoperative pain at rest was assessed using the Visual Analog Scale (VAS) in both study groups at predefined postoperative time points.

    Postoperative hours 0, 2, 6, 12, and 24

Study Arms (2)

laparoscopic-assisted TAP Block

EXPERIMENTAL

Participants received a bilateral laparoscopic-assisted transversus abdominis plane (TAP) block after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg.

Procedure: laparoscopic-assisted transversus abdominis plane block

trocar-site local anesthetic infiltration

ACTIVE COMPARATOR

Participants received local anesthetic infiltration at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg.

Procedure: trocar-site local anesthetic infiltration

Interventions

Local anesthetic infiltration was performed at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg.

trocar-site local anesthetic infiltration

Bilateral laparoscopic-assisted transversus abdominis plane (TAP) block was performed after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg.

laparoscopic-assisted TAP Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • ASA physical status I-II
  • Uncomplicated acute appendicitis without perforation or phlegmon
  • Undergoing laparoscopic appendectomy
  • Written informed consent

You may not qualify if:

  • Allergy to local anesthetics
  • Systemic disease such as diabetes mellitus, chronic kidney failure, or bleeding diathesis
  • Infection at the block application site
  • Regular analgesic use for chronic pain
  • Alcohol or narcotic dependence
  • Intraoperative diagnosis of perforated or phlegmonous appendicitis
  • Conversion from laparoscopic to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Reserch Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AppendicitisPain, Postoperative

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

August 16, 2017

Primary Completion

January 6, 2018

Study Completion

January 6, 2018

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this study and related analysis outputs will be available from the corresponding author upon reasonable request.

Time Frame
Data will be available upon reasonable request following publication of the study results.
Access Criteria
De-identified individual participant data and related analysis outputs will be available to researchers upon reasonable request to the corresponding author.

Locations