A Study to Compare the Efficacy And Safety Of Different Adjuncts To Local Anaesthetic For Labor Pain

Not yet recruiting

• Conditions: Encounter for full-term uncomplicated delivery,

• Registration Number: CTRI/2023/06/053707
• Lead Sponsor: Shri B M Patil Medical College

Brief Summary

This study is a Randomized,Parallel Group study. This study consists of 2 groups where Group RD who will receive 0.1% Inj.Ropivacaine + 0.5mcg/ml Inj.Dexmedetomidine and Group RF who will receive 0.1% Inj. Ropivacaine +2 mcg/ml Inj. Fentanyl. 68 Primigravida in labor will be equally divided into these 2 groups of 34 each. This study will be conducted in Shri. B M Patil Medical College, Vijayapura, Karnataka, India. The primary outcome is to compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of the onset of epidural analgesia, duration of analgesia, rescue analgesic dose, Visual Analog Scale, maternal vitals such as heart rate, blood pressure, oxygen saturation. The secondary outcome is to observe Ramsay Sedation Scale of mother, APGAR score of baby and maternal side effects like pruritis, hypotension, nausea, vomiting, shivering, respiratory depression, bradycardia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Last Update Posted: 2023-08-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Primigravida with cephalic presentation ASA grade I and II Maternal age 19 to 35 years Term gestation more than or equal to 37 weeks Single fetus Cervical dilatation more than or equal to 4 cm.

Exclusion Criteria

Hypotension/ Hypertension Obesity Endocrine disorders Fetal compromise Preterm gestation Coagulopathies Allergy to study agents Contraindications to epidural analgesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare Dexmedetomidine and Fentanyl as adjuvants in epidural analgesia in terms of:	Cervical dilatation from more than or equal to 4 cm to time of delivery
The onset of epidural analgesia, duration of analgesia, rescue analgesic dose	Cervical dilatation from more than or equal to 4 cm to time of delivery
Visual Analog Scale(VAS)	Cervical dilatation from more than or equal to 4 cm to time of delivery
Maternal Vitals- Heart rate, Blood Pressure, Oxygen saturation	Cervical dilatation from more than or equal to 4 cm to time of delivery

Secondary Outcome Measures

Name	Time	Method
Ramsay Sedation Score	APGAR score of the baby

Trial Locations

Locations (1)

Shri B M Patil Medical College; 🇮🇳 Bijapur, KARNATAKA, India

Shri B M Patil Medical College

🇮🇳Bijapur, KARNATAKA, India

Reshma R S

Principal investigator

9496381213

reshmarajs001@gmail.com