Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Drug: Dexmedetomidine 0.5 mcg; Drug: Dexmedetomidine 1 mcg

• Registration Number: NCT05342844
• Lead Sponsor: Mansoura University

Brief Summary

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties

Detailed Description

This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-06
• Study Completion: 2023-06-14
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• Age from 19 to 40 years old
• American Society of Anesthesiologists (ASA) physical status II patients
• Singleton pregnancies with a gestational age of at least 37 weeks.
• Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

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Exclusion Criteria

• Age < 19 or > 40 years.
• Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
• Inability to comprehend or participate in the pain scoring system.
• Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
• Hypersensitivity to any drug used in the study.
• Any hypertensive disorders of pregnancy.
• Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
• Significant cardiovascular, renal or hepatic abnormalities.
• Patients with history of opioid intake, drug abusers or psychiatric patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-Dexmedetomidine 0.5	Dexmedetomidine 0.5 mcg	After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side
Group-Dexmedetomidine1	Dexmedetomidine 1 mcg	After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side

Primary Outcome Measures

Name	Time	Method
The time of the first postoperative analgesic requirement	during the first 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
heart rate (HR)	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours	beat per minute
The level of sedation	during the first 24 postoperative hours	using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the	during the first 24 postoperative hours	mg
The visual analog scale (VAS) scores during rest	during the first 24 postoperative hours	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Mean arterial blood pressure (MBP)	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours	mmHg
Patient satisfaction about the quality of postoperative analgesia	during the first 24 postoperative hours	poor = 1, fair = 2, good = 3, excellent = 4
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)	during the first 24 postoperative hours	incidence
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome	during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement	during the first 24 postoperative hours	11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively

Trial Locations

Locations (1)

Mansoura University-Emergency hospital-ICU; 🇪🇬 Mansoura, Egypt