TAP Block Study - A Prospective, Double-blind Randomised Trial to Assess the Efficacy of Ultrasound Guided Transversus Abdominis Plane Blocks Using Ropivacaine in Patients Undergoing Laparoscopic Abdominal Surgery.

A Prospective, Double-blind Randomised Trial to Assess the Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Blocks Using Ropivacaine in Patients Undergoing Laparoscopic Abdominal Surgery.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000727943

Acronym

Transversus Abdominis Plane (TAP) Block

Enrollment

142

Registered

2011-07-12

Start date

2011-07-15

Completion date

2012-12-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate whether the TAP block procedure using the local anaesthetic agent Ropivacaine is effective at managing pain in the first 24 hours after laparoscopic abdominal surgery.

Interventions

All patients enrolled in the study who are undergoing elective abdominal laparoscopic surgery. Intervention Procedure: A is ultrasound (US)-Guided single dose injection of local anaesthetic agent Ropivacaine (injected between the muscle layers in the abdomen after general anaesthesia has begun), with dose based on patient weight. Subjects will also receive Patient-Controlled Analgesia with Morphine (1mg per dose with 5 minute lockout) or Fentanyl (10mcg per dose with 5 minute lockout) administered intravenously at the discretion of the anaesthetist. Subjects allocated to the control group will receive Patient-Controlled Analgesia only. In both treatment groups the Patient-Controlled Analgesia will be administered for up to 4 days post-surgery or until no longer required.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing elective laparoscopic abdominal surgery by the three participating surgeons

Exclusion criteria

-Refuse or are unable to give written informed consent to participate in the study, or -receive an epidural anaesthetic or other loco-regional anaesthesia, or -are under 18 years of age, or -have severe renal impairment -receive an operation that involved incisions outside the abdominal wall (such as abdomino-perineal resections) or -have a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial

Outcome results