TAP Block: Does Volume Make a Difference?

Not Applicable

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Ropivacaine

• Registration Number: NCT01307215
• Lead Sponsor: McMaster University

Brief Summary

Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Detailed Description

Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.

Study Timeline

• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-02
• Study Start: 2011-04
• Status Verified: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• 18-70 years old
• total abdominal hysterectomy
• capable of completing informed consent
• no previous chronic opioid use
• no previous abdominal wall surgeries

Exclusion Criteria

• patient refusal
• contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
• local or systemic infection
• local anesthetic allergy
• BMI>35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
20mLs of 0.5% ropivacaine per side	Ropivacaine	-
30mLs of 0.33% ropivacaine per side	Ropivacaine	-
40mLs of 0.25% ropivacaine per side	Ropivacaine	-

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.	6 month	This will be shown as a number and a percenttage of patients recruited and randomized.

Secondary Outcome Measures

Name	Time	Method
Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.	48 hours	The assessor will measure the extend of the block distribution at the various time intervals.
Pain scores at 2,6,12,24, and 48 hours post-block.	48 hours	Using a visual analog scale, patient pain scores will be assessed.
Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.	48 hours	Record drug consumption at the time intervals
Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.	48 hours
Block failure rate.	48 hours	Block failure rate is defined as the lack of any sensory block following the TAP block.
Patient's overall satisfaction.	48 hours	Using a LIKERT score, patient satisfaction will be measured.
Discharge time from PACU.	24 hours	The time in which the patient is discharged from the recovery room.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada