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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02997124
Enrollment
143
Registered
2016-12-19
Start date
2016-04-30
Completion date
2016-11-30
Last updated
2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Alveolar bone grafting, delirium, early ambulation

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.

Interventions

PROCEDURElocal infiltration and TAP block

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

PROCEDURElocal infiltration only

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

Sponsors

Jubilee Mission Medical College and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 22 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean pain scoresFirst hour after extubationMean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
Emergence deliriumFirst hour after extubationEmergence delirium was assessed using WATCHA Scale during the first hour after extubation
Pain scores24 hours after surgeryPain scores using the five - point verbal ranking score 24 hours after surgery
Ambulatory status24 hours after surgeryAmbulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery

Secondary

MeasureTime frameDescription
Infection and delayed healing at the graft harvest site6 weeks after surgeryAll 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 site12 weeks after the surgeryAll the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026