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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997124
• Other study ID #: 07/16/IEC/JMMC&RI
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 20, 2016
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Jubilee Mission Medical College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• local infiltration and TAP block
Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
• local infiltration only
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

References & 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. — 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

Outcome

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