Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Dexmedetomidine on the Quality of Recovery in Parturients Undergoing Elective Caesarean Sections: a Randomized Comparative Study

Conditions
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The Quality of Recovery (ObsQOR-11)

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group(A)<br>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. | Drug: Dexmedetomidine<br>* All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests. Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.<br>|
| Active Comparator: Group (B)<br>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. | Drug: Dexmedetomidine<br>* All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests. Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.<br>|
| Active Comparator: Group (C)<br>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. | Drug: Dexmedetomidine<br>* All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications. The required laboratory work will be: complete blood count (CBC); prothrombin time and concentration (PT&PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT); liver function tests and kidney function tests. Before arrival to the operation room (OR), women will be premedicated by metoclopramide 10mg and ranitidine 50 mg intravenous. Intra operatively, hemodynamics will be recorded baseline before spinal anaesthesia , after its performance, every 3 minutes until delivery and then every 10 minutes till the end of the CS. Any change within 20% of baseline will be accepted and any changes more than 20% will be managed according to guidelines. All groups will be anaesthetized to preform CS with conventional spinal anaesthesia. The TAP block group will receive a landmark orientated Ultrasound guided bilateral TAP block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery score following CS (ObsQor-11) at the end of the first 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). | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first request of analgesia in hours | from time of spinal anesthesia to the first registration of VAS score more than 3 | within 24 hours postoperative | 
| Ramsay sedation scale | Awake; agitated or restless or both Awake; cooperative, oriented, and tranquil Awake but responds to commands only Asleep; brisk response to light glabellar tap or loud auditory stimulus Asleep; sluggish response to light glabellar tap or loud auditory stimulus Asleep; no response to glabellar tap or loud auditory stimulus | 1, 2, 4, 6, 8, 12 and 24 hours | 
| Intra operative non-invasive mean blood pressure | in mmhg | within 24 hours postoperative | 
| Intra operative heart rate | beats per minutes | within 24 hours postoperative | 
| Visual Analogue Scale | VAS score at rest and during movement and cough The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') | 1, 2, 4, 6, 8, 12 and 24 hours postoperative | 
| Nausea and vomiting | Nausea and vomiting | intraoperative and postoperative 24 hours | 
| Onset of motor block using Bromage scale | defined as the time from giving spinal anesthesia until a modified Bromage score of IV will be reached),Duration of motor block (defined as the time from spinal anesthesia until Modified Bromage score of I). | Post spinal anesthesia up to 30 minutes | 
| Onset of sensory block | defined as the time needed to lose cold sensation when using the ice-cold test at the T6 dermatome level) and time to 2-segment regression of spinal anesthesia. | Post spinal anesthesia up to 30 minutes | 
| Neonatal Apgar score | This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. | at 1 and 5 minutes post delivery | 
| Complications of spinal anaesthesia and TAP block | Complications of spinal anaesthesia and TAP block | 12 hours post operative period. | 
| Incidence of hypotension | systolic blood pressure < 90 or <70% of baseline | post spinal anesthesia up to 1 hour | 
| Incidence of bradycardia | heart rate less than 60 beats per minute | post spinal anesthesia up to 1 hour |