NCT02997124

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

December 15, 2016

Last Update Submit

December 20, 2016

Conditions

Pain, Postoperative

Keywords

Alveolar bone graftingdeliriumearly ambulation

Outcome Measures

Primary Outcomes (4)

  • Mean pain scores

    Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,

    First hour after extubation

  • Emergence delirium

    Emergence delirium was assessed using WATCHA Scale during the first hour after extubation

    First hour after extubation

  • Pain scores

    Pain scores using the five - point verbal ranking score 24 hours after surgery

    24 hours after surgery

  • Ambulatory status

    Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery

    24 hours after surgery

Secondary Outcomes (2)

  • Infection and delayed healing at the graft harvest site

    6 weeks after surgery

  • Chronic pain, numbness or discomfort at graft harvest site

    12 weeks after the surgery

Study Arms (2)

Local Infiltration with TAP block

EXPERIMENTAL

Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.

Procedure: local infiltration and TAP block

Local Infiltration only

EXPERIMENTAL

Local Infiltration with 0.2% Ropivacaine.

Procedure: local infiltration only

Interventions

local infiltration and TAP blockPROCEDURE

Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done

Local Infiltration with TAP block
local infiltration onlyPROCEDURE

Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.

Local Infiltration only

Eligibility Criteria

Age4 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Chiono J, Bernard N, Bringuier S, Biboulet P, Choquet O, Morau D, Capdevila X. The ultrasound-guided transversus abdominis plane block for anterior iliac crest bone graft postoperative pain relief: a prospective descriptive study. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):520-4. doi: 10.1097/AAP.0b013e3181fa117a.

    PMID: 20975466BACKGROUND

  • Sandhu HS, Grewal HS, Parvataneni H. Bone grafting for spinal fusion. Orthop Clin North Am. 1999 Oct;30(4):685-98. doi: 10.1016/s0030-5898(05)70120-6.

    PMID: 10471772BACKGROUND

  • Heary RF, Schlenk RP, Sacchieri TA, Barone D, Brotea C. Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery. 2002 Mar;50(3):510-6; discussion 516-7. doi: 10.1097/00006123-200203000-00015.

    PMID: 11841718BACKGROUND

  • DeOrio JK, Farber DC. Morbidity associated with anterior iliac crest bone grafting in foot and ankle surgery. Foot Ankle Int. 2005 Feb;26(2):147-51. doi: 10.1177/107110070502600206.

    PMID: 15737257BACKGROUND

  • Silber JS, Anderson DG, Daffner SD, Brislin BT, Leland JM, Hilibrand AS, Vaccaro AR, Albert TJ. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003 Jan 15;28(2):134-9. doi: 10.1097/00007632-200301150-00008.

    PMID: 12544929BACKGROUND

  • Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.

    PMID: 19540168BACKGROUND

  • O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

    PMID: 16418039BACKGROUND

  • McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

    PMID: 17179269BACKGROUND

  • Kessler P, Thorwarth M, Bloch-Birkholz A, Nkenke E, Neukam FW. Harvesting of bone from the iliac crest--comparison of the anterior and posterior sites. Br J Oral Maxillofac Surg. 2005 Feb;43(1):51-6. doi: 10.1016/j.bjoms.2004.08.026.

    PMID: 15620775BACKGROUND

  • Zijderveld SA, ten Bruggenkate CM, van Den Bergh JP, Schulten EA. Fractures of the iliac crest after split-thickness bone grafting for preprosthetic surgery: report of 3 cases and review of the literature. J Oral Maxillofac Surg. 2004 Jul;62(7):781-6. doi: 10.1016/j.joms.2003.12.018.

    PMID: 15218554BACKGROUND

  • Rawashdeh MA, Telfah H. Secondary alveolar bone grafting: the dilemma of donor site selection and morbidity. Br J Oral Maxillofac Surg. 2008 Dec;46(8):665-70. doi: 10.1016/j.bjoms.2008.07.184. Epub 2008 Aug 29.

    PMID: 18760515BACKGROUND

  • Kalk WW, Raghoebar GM, Jansma J, Boering G. Morbidity from iliac crest bone harvesting. J Oral Maxillofac Surg. 1996 Dec;54(12):1424-9; discussion 1430. doi: 10.1016/s0278-2391(96)90257-8.

    PMID: 8957121BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeDelirium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsConfusionNeurobehavioral ManifestationsNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Vigil Peter, MD

    Jubilee Mission Medical College and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Anesthesia

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 19, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share