Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06076707 |
| Other study ID # |
1989156 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2023 |
| Est. completion date |
June 2, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Wollo University |
| Contact |
Aynalem Bf Woldemichael, MSC |
| Phone |
251916583316 |
| Email |
aynalembefkadu31[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study's clinical trial is to compare in post-operative analgesic
effectiveness of wound infiltration using bupivacaine, tramadol, and tramadol plus
bupivacaine in patients undergoing elective cesarean section under spinal anesthesia. The
main question the study aimed to answer is "which approach is best among the 3"
all participants need to respond to the pain severity for the data collectors and they will
receive treatments accordingly There will be 3 groups in the study
- group T: for tramadol
- group B: for bupivacaine
- group TB : tramadol + bupivacaine
Description:
Source Population: All parturients who are scheduled for elective cesarean delivery under
spinal anesthesia at Dessie Comprehensive Specialized Hospital
Sample size determination: since there is no previous study done with this title in the study
area, we take from a previous study done by Sahmeddini et al in India in the same population.
We choose the "time for the first request of analgesia" variable because we found a larger
sample size with this variable using the G*Power application. Using G*Power (using version
3.1.9.2) with a power of 80% and confidence interval of 95%, we estimated 153 participants,
and considering dropout and nonresponse (10% contingency) a total of 163 patients (54 in each
group) would be needed.
Sampling procedure
A 5-month logbook report of the hospital showed that around 400 patients undergo elective
c/s. 163 patients will be recruited with a probability of 24% until the sample size is
achieved by considering the sequential patients scheduled for C/S as the sampling frame. All
patients have a 50% equal chance of being included in the study. The first patient will be
recruited by lottery method and then every 2nd will be included until the required sample
size is completed. After informed consent is taken, eligible participants will be allocated
to one of the two groups with a sealed non-transparent envelope containing the name of the
study group
Data collection procedure:
4 anesthetists will be trained by the principal investigator about "how to perform their
given tasks" in the research for 5 days. There will be 2 BSC anesthetists dedicated to data
collection, 1 BSC anesthetist maintaining randomization and preparing the drugs, and 1 MSC
anesthetist performing local infiltration. Explanation about the study and taking written
informed consent will be done by the data collectors. The routine peri-operative spinal
anesthesia care will be maintained and the interventional drugs will be administered at the
end of the procedure before wound closure. The data collector will meet the patient in PACU
for the second time and start to assess pain intensity, tramadol consumption, time for the
first analgesic request as well as adverse side effects using systematically structured
questionnaires and chart review. The supervisors will assist and supervise the data
collection process. All data collectors will be BSc anesthetists who have three years of
experience. An evaluation will be performed at eight different time points: T0, T2, T4, T6,
T8, T12, T18, and T24. Collected data will be checked for completeness, accuracy, and clarity
by the principal investigator and the supervisors. For measuring and comparing the intensity
and prevalence of pain, NRS has been found to be reliable in a rural population irrespective
of literacy status(29)
Blinding
The data collector, patient, and primary investigators will be blinded about the components
of drugs in the wound infiltration. The interventional drugs will be prepared by another
anesthetist who will not participate in data collection or as an investigator. He/ she will
prepare an envelope that will be generated by computer software for all study participants
and held sealed until the day of surgery. On the day of surgery after they change clothes the
mother will pick up the envelope that will open by one anesthetist who will be responsible
for writing the generated random number and letter as TB for tramadol + bupivacaine group and
T for tramadol group and B for bupivacaine group.
Data quality management
Training will be given to data collectors regarding study tools, objectives of the study,
rights of respondents, and confidentiality of the information. To ensure the quality of data,
we will check out for completeness, accuracy, and clarity before data entry. The complete
data will enter into the SPSS version 22 computer program. Data clean-up and cross-checking
will before analysis.
Data processing and statistical analysis
Data will be checked, coded, entered, and analyzed by SPSS version 22 computer program. The
normality of data will be checked by K using the Shapiro-Wilk normality test and homogeneity
of variance by Levene's test. The presence of Outliers will also be assessed by a boxplot.
Analysis of variance (ANOVA) and Kruskal-Wallis H test will be used for normally distributed
continuous data and non-normally distributed or non-parametric data respectively. If these
ANOVAs or Kruskal-Wallis H test e significant, then Tukey post hoc test was used to compare
one group with the others. Categorical data will be analyzed using the Pearson Chisquared
test. Data were expressed as a mean and standard deviation (SD) and Median (Q1-Q3).
Frequency, percentages, tables, and figures will be used to summarize data. Data will be
expressed in terms of mean ± SD for normally distributed data or median (interquartile range)
for skewed data. P-value < 0.05 with a power of 80% is considered statistically significant.
Standard operating procedure (Anesthesia protocol) Step 1: Preparation A standard
preoperative assessment will be done for all parturients one day before the surgery. All
mothers will receive premedication (dexamethasone 8mg, metoclopramide 10mg, and cimetidine
200mg). All necessary equipment like anesthesia mashie, suction machine, oxygen supply,
vaporizers, Pulse oximetry, ECG, BP, Capnography (if applicable), Face mask, Oro pharyngeal
airway, ETT, LMA (if appropriate), Boogie or Stylet and the spinal set will be checked and
prepared. Availability of inductional, relaxants, antiemetics, analgesia, Local anesthetics,
and emergency drugs should be checked before the parturient enters the OR. We may not need
all these equipment and drugs for SA but we may face failed spinal, high spinal, or total
spinal so we should have a backup plan.
Step 2: SA administration and intra-op SA management After the mother entered the OR and is
placed on the OR table, SA will be performed by one BSC anesthetist between L3-L4 interspace
at sitting position by using tuffers line as a landmark with a 25 gauge spinal needle and
12.5 ml of 0.5% isobaric bupivacaine at a rate of 0.2 ml per second. Then routine
intraoperative SA care will be provided for all parturients.
Step 3: Wound infiltration All interventional drugs will be prepared 10 minutes before the
end of surgery in a 10cc syringe. At the end of surgery before wound closure, group T will
receive 2 mg/kg tramadol, group B will receive 0.25% of 0.7ml/kg bupivacaine and TB will
receive a combination of tramadol (2mg/kg and bupivacaine (0.25%, 0.7ml/kg) as wound site
infiltration by MSC anesthetist. Then after checking vital signs, all parturients will
transfer to PACU and will meet the data collector for the second time.
Operational definition Wound infiltration: the analgesic technique of administering local
anesthetic with or without additives directly into the surgical incision at the end of the
procedure.
Acute postoperative pain: is the pain experienced immediately after an operation, usually
lasting for days or sometimes weeks Chronic pain: is any pain that remains or keeps coming
back for more than 3 months or for longer than the expected healing time.
Chronic post-surgical pain: pain that develops after a surgical procedure that lasts for at
least three months.
Postoperative pain: when patients complain about the presence of pain after an operation or
any pain score other than zero within 24 hours.
Cesarean delivery: delivery of a fetus through surgical incisions made through the abdominal
wall (laparotomy) and the uterine wall (hysterectomy) Elective cesarean delivery: cesarean
delivery is done before the onset of labor when surgeons decided.
NRS: Is a valid pain intensity assessment tool that involves asking a patient to rate his or
her pain from 0-10 (11-point scale) with the understanding that 0 is equal to no pain and 10
equal to the worst possible pain Total analgesic consumption: the total amount of analgesic
drugs in milligrams used in the first 24 hours after the operation.
Time to first analgesic request: is a time in minutes measured from the end of the procedure
to the time when the patient requests analgesics.
Duration of surgery: time in minutes from skin incision to end skin closure. Duration of
anesthesia: a time in minutes it takes from administration of induction agent to the time a
patient is intubated.
