Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?

December 20, 2016 updated by: Dr. Vigil Peter, Jubilee Mission Medical College and Research Institute

Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters

The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane block administered intraoperatively improves the postoperative parameters in patients undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there is a decrease in the incidence of chronic pain or numbness at the harvest site.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomised, parallel group, single - centre trial evaluating the postoperative parameters in patients receiving supplemental Transversus Abdominis Plane block for anterior iliac crest harvest. It was conducted in 143 patients undergoing Alveolar bone grafting with iliac crest bone graft.

Methodology:

Informed consent and approval of local ethics and research committee in Jubilee Mission Medical College and Research Institute, Thrissur, India was obtained prior to initiation of the study. A pilot study was done to determine the efficacy of the additional TAP block. The results showed that the intervention improved patient analgesia and reduced the requirement for rescue analgesics. A minimum sample size of 65 patients was calculated for each group to obtain a power of 80% and confidence interval of 95%. 143 patients aged between 7 and 22 years posted for Alveolar bone grafting with anterior iliac crest harvest were assessed in the study. Only those undergoing Alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate were considered for the study. The patients who had difficulty in mentation and communication,bleeding disorders, hepatic problems, infection of the abdominal wall, renal dysfunction as well as allergy to the local anaesthetic were excluded from the study. Patients undergoing revision surgeries were also excluded from the study. All the candidates were randomly alloted to either of the two groups, using a computer - generated number.

All the patients were premedicated with Midazolam 0.15mg kg-1 and Glycopyrolate 0.01mg kg-1 Anaesthesia was induced with Propofol 2 mg kg -1 and Fentanyl 2 mcg kg-1 .Vecuronium 0.1 mg kg-1 was given to facilitate orotracheal intubation with a cuffed tube.Anaesthesia was maintained with oxygen, nitrous oxide and sevoflurane. Prior to incision, all the patients were given wound infiltration with 0.75 ml kg-1 of 0.2% Ropivacaine at the graft harvest site. Those in group A received an additional ultrasound guided Transversus Abdominis Plane block with a similar volume and concentration of Ropivacaine.

At the end of the surgical procedure, the patients were extubated awake, after giving I / V Neostigmine 0.05 mg kg-1. Just prior to extubation, I/V Tramadol 0.5 mg kg-1 was given for the pain in the postoperative period. In the recovery room, the pain and emergence delirium were assessed by an independent observer every ten minutes during the first postoperative hour.These were evaluated using the FLACC Behavioural Pain Assessment Scale and WATCHA Scale respectively. They were subsequently shifted to the postoperative ward.

The next time point of assessment was 24 hours post - surgery, when the patient's pain and ambulatory status were evaluated. The pain was ranked using the five - point verbal ranking score. It was ranked as no pain, light pain, moderate pain, severe pain and intolerable pain, with a score of 0,1,2,3 and 4 respectively. The total number of rescue analgesics demanded by the patient on the first postoperative day was noted.Ambulatory status was graded using one - day Cumulated Ambulatory Score.

The patients were followed up and questioned at six weeks and twelve weeks post operatively for the presence of chronic pain, numbness or wound healing problems at the harvest site.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must undergo alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate

Exclusion Criteria:

  • Revision procedure
  • History of difficulty in mentation and communication
  • Bleeding disorders, hepatic problems or renal dysfunction
  • Allergy to local anaesthetic
  • Presence of infection of anterior abdominal wall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local Infiltration with TAP block
Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
Procedure: local infiltration and TAP block
Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
Experimental: Local Infiltration only
Local Infiltration with 0.2% Ropivacaine.
Procedure: local infiltration only
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pain scores
Time Frame: First hour after extubation
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
First hour after extubation
Emergence delirium
Time Frame: First hour after extubation
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
First hour after extubation
Pain scores
Time Frame: 24 hours after surgery
Pain scores using the five - point verbal ranking score 24 hours after surgery
24 hours after surgery
Ambulatory status
Time Frame: 24 hours after surgery
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection and delayed healing at the graft harvest site
Time Frame: 6 weeks after surgery
All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
6 weeks after surgery
Chronic pain, numbness or discomfort at graft harvest site
Time Frame: 12 weeks after the surgery
All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
12 weeks after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jubilee Mission Medical College and Research Institute

Investigators

  • Principal Investigator: Vigil Peter, MD, Jubilee Mission Medical College and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/16/IEC/JMMC&RI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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