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

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ClinicalTrials.gov Identifier: NCT02997124
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Vigil Peter, Jubilee Mission Medical College and Research Institute

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: local infiltration and TAP block Procedure: local infiltration only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

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.




Primary Outcome Measures :
  1. Mean pain scores [ Time Frame: First hour after extubation ]
    Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,

  2. Emergence delirium [ Time Frame: First hour after extubation ]
    Emergence delirium was assessed using WATCHA Scale during the first hour after extubation

  3. Pain scores [ Time Frame: 24 hours after surgery ]
    Pain scores using the five - point verbal ranking score 24 hours after surgery

  4. Ambulatory status [ Time Frame: 24 hours after surgery ]
    Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   4 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997124


Sponsors and Collaborators
Jubilee Mission Medical College and Research Institute
Investigators
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Principal Investigator: Vigil Peter, MD Jubilee Mission Medical College and Research Institute
Publications:

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Responsible Party: Dr. Vigil Peter, Assistant Professor, Department of Anesthesia, Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT02997124    
Other Study ID Numbers: 07/16/IEC/JMMC&RI
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Vigil Peter, Jubilee Mission Medical College and Research Institute:
Alveolar bone grafting
delirium
early ambulation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations