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

NCT04464616 | Completed DMC

• 1 other identifier: spinal additives in CS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numerical Rating Scale

  postoperative first day

• Maternal satisfaction

  postoperative first day

• Neonatal outcome

  time of delivery of fetus

Study Arms (3)

control group

PLACEBO COMPARATOR

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

Procedure: spinal anaesthesia

Dexmedetomidine group):

EXPERIMENTAL

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

Dexamethasone group

EXPERIMENTAL

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

Interventions

spinal anaesthesia 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.

Also known as: intrathecal anaesthesia

Dexamethasone group; Dexmedetomidine group):; control group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: July 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 20, 2021
• Last Updated: February 16, 2021

Record last verified: 2020-07

Locations

EG (1)