Clinical trial NCT05991466: Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections
Official title: The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: The Quality of Recovery (ObsQOR-11)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study hypothesizes that addition of dexmedetomidine to bupivacaine either in spinal anesthesia or TAP block is more effective and provide better ObsQor-11score than bupivacaine alone. Also, Dexmedetomidine in TAP block might provide a longer pain free time in comparison to intrathecal dexmedetomidine.

Detailed description: Aim of the work To compare the quality of recovery (ObsQOR-11) in patients undergoing cesarean sections receiving dexmedetomedine either intrathecally or in the tap block in comparison to patients receiving conventional spinal anesthesia and tap block.

Statistical Analysis I. Sample size In a pilot study on 5 parturient who had undergone elective cesarean section under spinal anesthesia followed by TAP block with bupivacaine alone, the mean ObsQoR-11 at 24 hours was 65±9. In a single factor ANOVA study, sample size of 126 from the 3 groups is needed to detect a difference of at least 10 using the Tukey-Kramer (Pairwise) multiple comparison with study power of 83% and alpha error of 0.05. The common standard deviation within a group is assumed to be 9. The number of envelopes will be increased to 141 (47 per group) to compensate of possible 10% dropout. The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

II. Statistical analysis Data will be coded and entered using the statistical package SPSS (statistical package for the social science) version 22. Data will be summarized using mean, standard deviation, median, minimum and maximum in quantitative data and using frequency (count) and relative frequency(percentage)for categorical data. Comparisons between quantitative variables will be done using the non parametric Mann-Whitney test. For comparing categorical data, Chi square (x2 ) test will be performed. Exact test will be used instead when the expected frequency is less than 5. P-value less than 0.05 will be considered as statistically significant.

Eligibility criteria: Inclusion Criteria:

* Participants will be full-term pregnant females
* ASA classification I or ll.
* Aged between 18 and 40 years.
* Singleton pregnancy

Exclusion Criteria:

* Refusal of block.
* Bleeding disorders (platelets count \<150,000; INR\>1.5; PC\<60%).
* wounds or infection at the puncture site.
* Known allergy to local anesthetic drugs.
* Contraindications to neuroaxial block.
* Contraindications to TAP block..

Primary outcomes:
measure: Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Time of first request of analgesia in hours
timeFrame: within 24 hours postoperative
measure: Ramsay sedation scale
timeFrame: 1, 2, 4, 6, 8, 12 and 24 hours
measure: Intra operative non-invasive mean blood pressure
timeFrame: within 24 hours postoperative
measure: Intra operative heart rate
timeFrame: within 24 hours postoperative
measure: Visual Analogue Scale
timeFrame: 1, 2, 4, 6, 8, 12 and 24 hours postoperative
measure: Nausea and vomiting
timeFrame: intraoperative and postoperative 24 hours
measure: Onset of motor block using Bromage scale
timeFrame: Post spinal anesthesia up to 30 minutes
measure: Onset of sensory block
timeFrame: Post spinal anesthesia up to 30 minutes
measure: Neonatal Apgar score
timeFrame: at 1 and 5 minutes post delivery
measure: Complications of spinal anaesthesia and TAP block
timeFrame: 12 hours post operative period.
measure: Incidence of hypotension
timeFrame: post spinal anesthesia up to 1 hour
measure: Incidence of bradycardia
timeFrame: post spinal anesthesia up to 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
References: