Clinical trial

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

Name
TAP-dexmedetomidine
Description
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
Trial arms
Trial start
2022-05-01
Estimated PCD
2022-12-31
Trial end
2023-06-14
Status
Completed
Treatment
Dexmedetomidine 0.5 mcg
0.5 mcg/kg
Arms:
Group-Dexmedetomidine 0.5
Dexmedetomidine 1 mcg
1 mcg/kg
Arms:
Group-Dexmedetomidine1
Size
81
Primary endpoint
The time of the first postoperative analgesic requirement
during the first 24 postoperative hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}
Updated at
2023-06-23

1 organization

1 product

1 indication

Indication
Analgesic