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

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

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.

Study Overview

• Status: Completed
• Conditions: The Quality of Recovery (ObsQOR-11)
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11562
      • Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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..

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Dexmedetomidine; 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.
Active Comparator: 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.	Drug: Dexmedetomidine; 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.
Active Comparator: 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.	Drug: Dexmedetomidine; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: MD-172-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No