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Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section

The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04464616
Enrollment
90
Registered
2020-07-09
Start date
2020-07-15
Completion date
2021-01-20
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

PROCEDUREspinal anaesthesia

spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
time for the first request of rescue analgesiapostoperative first daytime for the first request of rescue morphine analgesia at dose of 3 mg

Secondary

MeasureTime frameDescription
Numerical Rating Scalepostoperative first dayNumerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is \>3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
Maternal satisfactionpostoperative first dayMaternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).
Neonatal outcometime of delivery of fetusNeonatal outcome will be assessed in terms of Apgar score.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026