Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Dow University of Health Sciences60 enrolled

Overview

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cesarean Section Complications

Interventions

Bupivacaine, fentanylDRUG

Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,

Bupivacaine, dexmedetomidineDRUG

Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Term pregnancy Singleton ASA I and II, BMI \<35, elective C/section Exclusion Criteria: patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Locations (2)

Civil Hospital Karachi

Karachi, Sindh, Pakistan

DUHS, Civil hospital Karachi (CHK)

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Time till T10 dermatome achieved (Sec)

Spinal block characteristics

Time frame: Post operative initial hour

Time of maximum bromage achieved (Sec)

Spinal block characteristics

Time frame: Post operative initial hour

Regression time to T10 dermatome (Min)

Spinal block characteristics

Time frame: Post operative initial hour

Time of complete motor recovery (Min)

Spinal block characteristics

Time frame: Post operative initial hour

Post-operative pain score

VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

Time frame: 1 hour

Post-operative pain score

VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

Time frame: 2 hour

Post-operative pain score

VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

Time frame: 3 hour

Post-operative pain score

VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

Time frame: 4 hour

Secondary Outcomes

Nausea

Sensation to throw out stomach contents

Data from ClinicalTrials.gov

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