The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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..
Arms & Interventions
Group(A)
Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg and TAP block will be performed with 30 ml 0.25% bupivacaine in each side.
Intervention: Dexmedetomidine (Drug)
Group (B)
Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine10-12 mg and TAP block will be performed with 50 mcg Dexmedetomidine added to 30ml 0.25% bupivacaine in each side.
Intervention: Dexmedetomidine (Drug)
Group (C)
Spinal anaesthesia will be performed with 0.5% hyperbaric bupivacaine 10-12 mg added to 5 mcg dexmedetomidine. TAP block will be performed with 30ml 0.25% bupivacaine in each side.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Quality of recovery score following CS (ObsQor-11) at the end of the first 24 hours postoperative.
Time Frame: 24 hours postoperative
The mothers will be asked to rate each recovery item with an 11-point numerical Likert scale (0 = strongly negative; 10 = strongly positive).
Secondary Outcomes
- Time of first request of analgesia in hours(within 24 hours postoperative)
- Onset of sensory block(Post spinal anesthesia up to 30 minutes)
- Incidence of bradycardia(post spinal anesthesia up to 1 hour)
- Incidence of hypotension(post spinal anesthesia up to 1 hour)
- Neonatal Apgar score(at 1 and 5 minutes post delivery)
- Intra operative non-invasive mean blood pressure(within 24 hours postoperative)
- Complications of spinal anaesthesia and TAP block(12 hours post operative period.)
- Ramsay sedation scale(1, 2, 4, 6, 8, 12 and 24 hours)
- Intra operative heart rate(within 24 hours postoperative)
- Visual Analogue Scale(1, 2, 4, 6, 8, 12 and 24 hours postoperative)
- Onset of motor block using Bromage scale(Post spinal anesthesia up to 30 minutes)
- Nausea and vomiting(intraoperative and postoperative 24 hours)
Investigators
Mohamed Ahmed Mohamed Youssef Ollaek
Assistant Professor
Cairo University