To Evaluate and study analgesic effect of fentanyl as an additive to intrathecal hyperbaric ropivacaine for lower limb surgery
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/05/052455
- Lead Sponsor
- Dr. Sarvjeet Kaur
- Brief Summary
INTRODUCTION: Spinal anaesthesia has been a widely used, safe and effective form of anaesthesia for lower abdominal and extremity surgeries. Intrathecal ropivacaine as a local anaesthetic drug has been introduced into clinical practice as it meets the desired goals of anaesthesia while minimizing the potential side effects. The addition of different adjuvants along with local anaesthetic has shown to have synergistic effect by prolonging the analgesic property and the duration of sensory-motor blockade and decreasing the dose requirement of local anaesthetic. Fentanyl in this regard has also shown some promising effects. The addition of intrathecal fentanyl to ropivacaine may improve the quality of block and early postoperative mobility. Thus we compare the use of ropivacaine along with an adjunct (fentanyl) versus a single agent to attain the desired anesthetic effect while minimizing the associated side effects.
AIMS AND OBJECTIVES: Our aim is to compare analgesic efficacy of intrathecal ropivacaine with fentanyl versus ropivacaine alone in lower limb surgeries.We will compare the onset and duration of sensory blockade and motor blockade and maximum height of sensory blockade achieved. We will also look for safety and side effects, if any in both the groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
- 1.Patients scheduled for elective lower limb surgeries under spinal anaesthesia.
- 2.Patients aged between 18-60 years of either gender, giving valid informed and written consent.
- 3.Patients belonging to American Society of Anaesthesiology (ASA) grade I and II.
1.Patient with Known allergy to drugs used in study 2.Any contraindications to spinal anaesthesia 3.Coagulopathy and bleeding diathesis 4.Patients diagnosed with psychiatric ailments 5.History of drug/substance abuse 6.Patients on anti arrhythmic treatment BMI>35 kg/m2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study duration of analgesia with intrathecal ropivacaine in lower limb surgery. Outcome will be assessed at the end of study that is 12 months 2.To study duration of analgesia with intrathecal ropivacaine and fentanyl in lower limb surgery. Outcome will be assessed at the end of study that is 12 months 3.To compare duration of analgesia with intrathecal ropivacaine versus intrathecal ropivacaine with fentanyl in lower limb surgery. Outcome will be assessed at the end of study that is 12 months
- Secondary Outcome Measures
Name Time Method NA NA
Trial Locations
- Locations (1)
GGSMCH
🇮🇳Faridkot, PUNJAB, India
GGSMCH🇮🇳Faridkot, PUNJAB, IndiaDr AASHIMA MAHAJANPrincipal investigator7009055386aashimamahajan89@gmail.com