Comparison of two drugs buprenorphine and dexmedetomedine given intrathecally in pregnant patients undergoing caesarean section.

Not yet recruiting

• Conditions: Factors influencing health status and contact with health services, (2) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy,

• Registration Number: CTRI/2022/08/044572
• Lead Sponsor: ESIC Medical College Gulbarga

Brief Summary

Subarachanoid block is the anaesthetic technique of choice in pregnant patients with low risk pregnancy undergoing caesarean section since it provides easy and rapid induction with effective sensory and motor bloackade with no significant effects on fetus.Intrathecal Ropivacaine has gained popularity as an alternative to intrathecal Bupivacaine hydrochloride because of its reduced risk of carditoxicity, neurotoxicity and good haemodynamic stability. Ropivacaine has its own limitation of short duration of anaesthesia, which can be overcome by adding adjuvants to local anaesthetics. The supplementation of local anaesthetics with adjuants is done to reduce the dose of local anaesthetics, minimise the side effects and prolong the duration of intra and post-operative analgesia with good haemodynamic stability. From time to time, various methods including addition of adjuants to local anaesthetics have been tried but with a varying success. Many studies using adjuants like opoids and alpha-2 agonist to bupivacaine are available in literature whereas few studies have been done using these adjuants with ropivacaine. On searching the literature , we did not come across any study comparing the effects of buprenorphine and dexmedetomedine with intrathecal hyperbaric Ropivacaine 0.75% in pregnant patients and better adjuant among these two agents still needs to be explored. Hence the study is conducted to assess the effectiveness of buprenorphine versus dexmedetomedine when used as adjuants to intrathecal hyperbaric ropivacaine 0.75% for prolongation of inta and post-operative analgesia in pregnant patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-08
• Study Start: 2022-04-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Parturients with 1.Singleton pregnancy, scheduled for elective caesarean section under spinal anaesthesia 2.More than 36 weeks of gestation age 3.18-40 years of age 4.Height between 140cm and 180cm 5.BMI less than 32kg/m2, 6.Nil per oral for more than 6 hours.

Exclusion Criteria

• 1.Multiple pregnancy 2.Morbid Obesity (BMI >40) 3.Height <140 cms & >170cms 4.Patients with spinal deformities and those who have undergone previous spine surgeries.
• 5.Pregnancy related hypertensive disease, preeclampsia, eclampsia.
• 6.Cardiovascular disease 7.Gestational diabetes requiring insulin.
• 8.Emergency caesarean sections for maternal or foetal distress.
• 9.Contraindication to spinal anesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the onset time and duration of sensory and motor block.	1. To study the onset time and duration of sensory and motor block in pregnant patients who receive the study drug. | 2. To know the time of first analgesic used. | 3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.
2. To know the time of first analgesic used.	1. To study the onset time and duration of sensory and motor block in pregnant patients who receive the study drug. | 2. To know the time of first analgesic used. | 3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.
3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.	1. To study the onset time and duration of sensory and motor block in pregnant patients who receive the study drug. | 2. To know the time of first analgesic used. | 3. To assess post-operative pain scores based on visual analog scale (VAS) at 2 hours, 6 hours and 12 hours after the surgery.

Secondary Outcome Measures

Name	Time	Method
1. To study hemodynamic parameters.	2. Side effects like hypotension, bradycardia, shivering, vomiting.

Trial Locations

Locations (1)

ESIC Medical College, Gulbarga.; 🇮🇳 Gulbarga, KARNATAKA, India

ESIC Medical College, Gulbarga.

🇮🇳Gulbarga, KARNATAKA, India

Dr Priyanka Y Kanni

Principal investigator

9908290999

priyankakanni@gmail.com