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

NCT ID: NCT04464616

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-01-20

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

control group

spinal anesthesia with 10 mg hyperbaric bupivacaine 5% (2 ml) + 25 μg fentanyl (0.5 ml) + normal saline (0.5 ml).

Group Type: PLACEBO_COMPARATOR

spinal anaesthesia

Intervention Type: PROCEDURE

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.

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).

Group Type: EXPERIMENTAL

spinal anaesthesia

Intervention Type: PROCEDURE

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.

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).

Group Type: EXPERIMENTAL

spinal anaesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

intrathecal anaesthesia

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

tarek abdel hay mostafa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tarek Abdel Hay

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

spinal additives in CS

Identifier Type: -

Identifier Source: org_study_id