Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local infiltration and TAP block
local infiltration only
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Alveolar bone grafting, delirium, early ambulation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Local Infiltration with TAP block
Local Infiltration only
Arm Description
Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
Local Infiltration with 0.2% Ropivacaine.
Outcomes
Primary Outcome Measures
Mean pain scores
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
Emergence delirium
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
Pain scores
Pain scores using the five - point verbal ranking score 24 hours after surgery
Ambulatory status
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
Secondary Outcome Measures
Infection and delayed healing at the graft harvest site
All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
Chronic pain, numbness or discomfort at graft harvest site
All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
Full Information
NCT ID
NCT02997124
First Posted
December 15, 2016
Last Updated
December 20, 2016
Sponsor
Jubilee Mission Medical College and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02997124
Brief Title
Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?
Official Title
Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jubilee Mission Medical College and Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Alveolar bone grafting, delirium, early ambulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local Infiltration with TAP block
Arm Type
Experimental
Arm Description
Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
Arm Title
Local Infiltration only
Arm Type
Experimental
Arm Description
Local Infiltration with 0.2% Ropivacaine.
Intervention Type
Procedure
Intervention Name(s)
local infiltration and TAP block
Intervention Description
Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
Intervention Type
Procedure
Intervention Name(s)
local infiltration only
Intervention Description
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.
Primary Outcome Measure Information:
Title
Mean pain scores
Description
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
Time Frame
First hour after extubation
Title
Emergence delirium
Description
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
Time Frame
First hour after extubation
Title
Pain scores
Description
Pain scores using the five - point verbal ranking score 24 hours after surgery
Time Frame
24 hours after surgery
Title
Ambulatory status
Description
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Infection and delayed healing at the graft harvest site
Description
All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
Time Frame
6 weeks after surgery
Title
Chronic pain, numbness or discomfort at graft harvest site
Description
All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
Time Frame
12 weeks after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vigil Peter, MD
Organizational Affiliation
Jubilee Mission Medical College and Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?
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