Dexmedetomidine versus Fentanyl in Femoral Nerve Block

Not yet recruiting

Conditions: Other Procedures,

Registration Number: CTRI/2021/12/038945

Lead Sponsor: Dr M K Shah Medical college and Research centre SMS multi speciality Hospital

Brief Summary: **Dexmedetomidine versus Fentanyl as an Adjunct to Bupivacaine in Femoral Nerve Block: A comparitive Study**

Aims:We intend to compare the effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia in lower limb surgeries.

**Patients and Methods**

All patients will be randomly assigned into two groups (40 patients each).

â€¢        Group BD (No. =40)

Â·         Group BF (No. =40)

Once fitness and primary assessment completed patient will be posted for surgery.

After shifting the patient to the induction room, ECG, pulse oximeter, noninvasive blood pressure monitors will be attached. Peripheral venous line will be established and an infusion of lactated ringersâ€™ solution will be started.

Then femoralnerve block will be performed

Technique of ultrasound guided femoral nerve block

In this procedure drug will be given as described below

**Group BD** (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 0.5 mcg/kg diluted in 2 ml saline to reach total volume 20 ml).

**Group BF** (No. =40): ultrasound guided femoral nerve block before spinal anesthesia will be done for each patient using (18 ml of 0.25% bupivacaine + 1mic/kg fentanyl diluted in 2 ml saline to reach total volume 20 ml).

before femoral nerve block (baseline),

â€¢        after block and before spinal anesthesia,

â€¢        immediately after spinal anesthesia, and

â€¢        every 30 minutes till end of surgery.

Ã˜ Visual Analogue Scalewill be used for pain measurement at regular intervals as primary tool of observation and will be recorded every 30 min post operatively until the first dose of rescue analgesic is given.

**Visual Analogue Scale:**

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients In The Age Range 20-60 Years.
ASA Risk Category I And II.
No Known History Of Allergy, Sensitivity Or Other Form Of Reaction To Local Anesthetics Of The Amide Type.

Exclusion Criteria

Patient Refusal.
Patients With Coagulopathy.
Patients On Potent Antiplatelets, Or On Anticoagulants.
Patients With Back & Spine Problems.
Patients With Local Skin Infections At Site Of Injection.
Known Allergy To The Trial Drugs.
Patients With Poor Myocardial Contractility.
Patients With Thoracic Spine Deformity.
ASA III Or More.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to compare the total duration of analgesia effect of dexmedetomidine and fentanyl as adjuvant to bupivacaine in femoral nerve block for postoperative analgesia .	Baseline, immediately after block, prior to spinal,5 mins ,30 mins,60 mins, 2 hours and 6 hourly thereafter
To calculate total analgesia requirement postoperatively.	Baseline, immediately after block, prior to spinal,5 mins ,30 mins,60 mins, 2 hours and 6 hourly thereafter

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scalewill be used for pain measurement	every 30 min post operatively until the first dose of rescue analgesic is given.
time of rescue analgesia	time at which first dose of analgesia given postoperatively

Trial Locations

Locations (1): Dr M K Shah Medical college and Research centre SMS multi speciality Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Dr M K Shah Medical college and Research centre SMS multi speciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Shah
Principal investigator
7567815075
parthshah1291@gmail.com