Clinical trial NCT05342844: Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 81
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: The time of the first postoperative analgesic requirement
timeFrame: during the first 24 postoperative hours
Secondary outcomes:
measure: Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
timeFrame: during the first 24 postoperative hours
measure: The visual analog scale (VAS) scores during rest
timeFrame: during the first 24 postoperative hours
measure: The visual analog scale (VAS) scores during movement
timeFrame: during the first 24 postoperative hours
measure: Mean arterial blood pressure (MBP)
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
measure: heart rate (HR)
timeFrame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
measure: Patient satisfaction about the quality of postoperative analgesia
timeFrame: during the first 24 postoperative hours
measure: The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
timeFrame: during the first 24 postoperative hours
measure: the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
timeFrame: during the first 24 postoperative hours
measure: The level of sedation
timeFrame: during the first 24 postoperative hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
References: