Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05442411 |
| Other study ID # |
USM/ JEPeM/19080504 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2021 |
| Est. completion date |
March 30, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Universiti Sains Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To compare the post cranioplasty pain score using scalp block versus conventional analgesia
using IV Parecoxib and requirement of morphine between two groups as rescue analgesia
Description:
This study involved a prospective, double-blinded randomized controlled trial which has been
approved by the Medical Research and Ethics Committee (JEPEM) of Universiti Sains Malaysia
(JEPeM Code: USM/ JEPeM/19100637).
Fifty-eight patients with written informed consent and American Society of Anaesthesiologist
(ASA) physical status I and II, aged 18 to 60 years old, pre-operative GCS of 15 and
underwent elective cranioplasty surgery under general anaesthesia (GA) between September 2019
until March 2022 were selected for the study and randomized by computer generated
randomization into two groups; Regional Scalp Block (n = 29) and IV Parecoxib (n = 29). The
patients were excluded from this study if they were a known allergy to local anesthesia or
NSAIDS, had risk for bleeding tendency or coagulopathy, low preoperative platelets count (<
100 x103/mL) or with underlying bronchial asthma. The patient withdrawn from the study if he
or she was not able to score post pain using Visual analog Scale (VAS) or had redo surgery
for postoperative bleeding.
During surgery, all of them were induced by standard anaesthesia protocol. They were given IV
fentanyl 1-2mcg/kg, IV propofol 2 mg/kg and IV rocuronium 0.6mg /kg. The anaesthesia was
maintained with sevoflurane with minimum alveolar concentration (MAC) of 1.0 to 1.2 with
mixture of air and oxygen. The intraoperative analgesia were IV Fentanyl 1-2mcg/kg and IV
paracetamol 1g. The total intraoperative analgesia dose was recorded in GA form and the
top-up muscle relaxant was given as needed upon evidence of rebreathing in the capnograph
waveform. At the end of the surgery, all subjects were reversed with IV neostigmine 0.05
mg/kg and atropine 0.02mg/kg.
The injection solution for both groups were prepared by the single anaesthesiologist who are
experience and familiar with scalp block procedure and IV Parecoxib. For the Group A, they
were given regional scalp block by using solution 0.375% ropivacaine and lidocaine 1% up to
20 ml. The same person was performed the Scalp Block by injecting the solution into
Supra-orbital & Supratrochlear (V1), Auriculo-temporal (V2), Post-auricular branches of the
Greater Auricular Nerves and Occipital nerves after the surgeon completed skin closure of the
scalp at the end of surgery (at the side that will be operated). Group B was injected IV
parecoxib 40mg during the closure of the scalp. All subjects will be reversed using standard
reversal and fulfil criteria for extubation before extubation Post cranioplasty operation,
both groups were given PCA Morphine as rescue analgesia if pain score ≥ 4. Both groups
received IV paracetamol 1g 6 hourly as additional analgesia.
Pain score was assessed by staff nurses in the ward (unrelated to study to avoid bias) by
using visual analogue scale (VAS) at interval hours of first, second, forth, sixth and
twelfth-hour post cranioplasty. The patient was withdrawn from the study if they had massive
bleeding or hemodynamically unstable or require intensive care and ventilatory support post
cranioplasty. The patients and post-operative assessors (the staff nurse in the ward) were
blind to avoid bias.
After 12 hours, the total requirement of morphine and time for request rescue analgesia were
recorded. The side effects of both methods were documented. Local anesthesia side effects
such as allergic reactions, local tissue, cardiovascular, central nervous system, and
systemic toxicity, infection, changes in wound healing, or increased wound drainage.
Parecoxib side effects such as bleeding, renal failure, and myocardial infarction.
The sample size was calculated using the G*Power Software (Version 3.1.9.7 by Franz Faul,
Universitat Keil, Germany. Based on the objective to compare effectiveness in pain control
between both groups using effect size f 0.30, power of 0.8, ɑ error probability 0.05, number
of groups 2 and number of measurements 5. It required 21 peoples in one group and a total
sample size of 42. These included a 10% dropout.
Data were analysed using IBM SPSS statistics version 26 software. All measurement data were
analysed for normal distribution and homogeneity variance. All demographic data between
groups were analysed using descriptive analysis and independent sample t-test for numerical
data and Chi-square analysis for categorical data. Differences in pain score using VAS
between two groups were analysed using one-way and two-way repeated ANOVA. Model assumptions
of normality and homogeneity of covariance were checked. Total morphine requirement and the
first time PCA were analysed using an independent sample t-test. The side effects of both
groups were analysed using the Chi-Square test. A P -the value of < 0.05 was regarded as
statistically significant.
