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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: spinal anaesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31527
      • Tarek Abdel Hay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control group; spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).	Procedure: spinal 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.; Other Names: intrathecal anaesthesia
EXPERIMENTAL: Dexmedetomidine group): spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 5 μg dexmedetomidine in a volume of (0.5 ml).	Procedure: spinal 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.; Other Names: intrathecal anaesthesia
EXPERIMENTAL: Dexamethasone group; spinal anaesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + 2 mg dexamethasone in a volume of 0.5 ml).	Procedure: spinal 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.; Other Names: intrathecal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for the first request of rescue analgesia	time for the first request of rescue morphine analgesia at dose of 3 mg	postoperative first day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale	Numerical 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.	postoperative first day
Maternal satisfaction	Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).	postoperative first day
Neonatal outcome	Neonatal outcome will be assessed in terms of Apgar score.	time of delivery of fetus

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ACTUAL): January 20, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: spinal additives in CS

Drug and device information, study documents

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