Clinical trial NCT04464616: Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section
Official title: The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.

Detailed description: Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal analgesia have been proposed. A meta-analysis by Popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects.

Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C- fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. Recent studies reported no complications associated with intrathecal dexamethasone.

Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al., in their meta-analysis showed that addition of intrathecal DEX significantly increased the duration of postoperative analgesia and reduced analgesic consumption. The increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.

Eligibility criteria: Inclusion Criteria:

* 90 parturient
* the statue of American Society of Anesthesiologists' physical class II
* prepared for an elective cesarean section.

Exclusion Criteria:

* BMI \> 35kg/m2
* gestational age \< 28 weeks
* diabetes or gestational diabetes
* hypertension or pre-eclampsia
* contraindications to spinal anesthesia
* height less than 160 Cm
* history of psychiatric disease
* taking α-receptor antagonist drugs -a history of allergy to the study drugs-
* excessive hemorrhage needing transfusion.

Primary outcomes:
measure: time for the first request of rescue analgesia
timeFrame: postoperative first day
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: postoperative first day
measure: Maternal satisfaction
timeFrame: postoperative first day
measure: Neonatal outcome
timeFrame: time of delivery of fetus
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tarek Abdel Hay
state: El Gharbyia
Study officials:
References: