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Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery

H

Hunter Colorectal Research

Status and phase

Completed
Phase 1

Conditions

Pain

Treatments

Procedure: US-Guided Ropivacaine TAP Block

Study type

Interventional

Funder types

Other

Identifiers

NCT00682136
08/02/20/3.02
TAPTRIAL

Details and patient eligibility

About

The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.

TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.

This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.

Enrollment

206 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.

Exclusion criteria

  • History of adverse reaction to Ropivicaine or similar drug.
  • Inability or refusal to give consent
  • Coagulopathic
  • Severe renal impairment
  • Aged <18 years

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

206 participants in 2 patient groups

1
Active Comparator group
Description:
Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.
Treatment:
Procedure: US-Guided Ropivacaine TAP Block
2
Active Comparator group
Description:
Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.
Treatment:
Procedure: US-Guided Ropivacaine TAP Block

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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