Pain, Postoperative Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | November 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 22 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Jubilee Mission Medical College and Research Institute |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation
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. Erratum in: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added]. — View Citation
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. Review. — View Citation
Sandhu HS, Grewal HS, Parvataneni H. Bone grafting for spinal fusion. Orthop Clin North Am. 1999 Oct;30(4):685-98. Review. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean pain scores | Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale, | First hour after extubation | No |
Primary | Emergence delirium | Emergence delirium was assessed using WATCHA Scale during the first hour after extubation | First hour after extubation | No |
Primary | Pain scores | Pain scores using the five - point verbal ranking score 24 hours after surgery | 24 hours after surgery | No |
Primary | Ambulatory status | Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery | 24 hours after surgery | No |
Secondary | 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. | 6 weeks after surgery | No |
Secondary | 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 | 12 weeks after the surgery | No |
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