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

Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery

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

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine 0.5 mcg; Drug: Dexmedetomidine 1 mcg

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

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Mansoura University-Emergency hospital-ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group-Control; 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 0.9% for each side
Active Comparator: Group-Dexmedetomidine 0.5; 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	Drug: Dexmedetomidine 0.5 mcg; 0.5 mcg/kg
Active Comparator: Group-Dexmedetomidine1; 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	Drug: Dexmedetomidine 1 mcg; 1 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time of the first postoperative analgesic requirement	during the first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the	mg	during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest	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	during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement	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	during the first 24 postoperative hours
Mean arterial blood pressure (MBP)	mmHg	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)	beat per minute	basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia	poor = 1, fair = 2, good = 3, excellent = 4	during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)	incidence	during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome		during the first 24 postoperative hours
The level of sedation	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)	during the first 24 postoperative hours

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: TAP-dexmedetomidine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No