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