Use of 2-chloroprocaine by adding fentanyl and dexmedetomidine in short duration orthopaedic surgeries

Phase 4

Not yet recruiting

• Conditions: Injuries to the knee and lower leg,

• Registration Number: CTRI/2020/07/026388
• Lead Sponsor: Sri Venkateswara Institute of Medical Sciences

Brief Summary

This study is to compare the efficacy of fentanyl and dexmedetomidine as an adjuvants to intrathecal 2-chloroprocaine among the patients posted for elective lower limb orthopaedic surgeries.

4ml of 2-chloroprocaine is the study drug in which 25 mcg of preservative free fentanyl is added as an adjuvant in one group and 5 mcg of dexmedetomidine  is added in another group.

Study ends when patient complains pain after giving the drug.

onset,duration of sensory and motor block ,height of the sensory block, regression time of L1 dermatome is studied.

Visual Analog Scale(VAS), and Visual analogue Scale of patient satisfaction (VAS scores of patient satisfaction) is used to assess the pain and satisfaction at the drug in patient.

Adverse effects of the study drugs will be studied and manageed  during study period .

Our study intends to prove that 2-chloroprocane can be used by adding adjuvants such as fentanyl and dexmedetomidine in short duration lower limb orthopaedic surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-07
• Study Start: 2020-07-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients of American society of Anesthesiologists physical status grade 1 and 2 2.
• Patients of age group between 20 to 65 years 3.
• patients posted for elective lower limb orthopaedic surgeries with duration of 1.5 to 2 hrs.

Exclusion Criteria

• Patients who are not willing to participate in the study.
• Patients who do not give consent for spinal anaesthesia.
• H/o spinal surgeries.
• H/o coagulation and bleeding disorders.
• Local site infections.
• H/o hypersensitivity to study drugs.
• H/o uncontrolled HTN and DM & H/o CAD.
• Increased serum creatinine and liver enzymes: 2-3 times of normal.
• H/o neuropsychiatric disorders and communication problems 10.
• Patients who cannot understand visual analog scale (VAS) measurements.
• Pregnant women and lactating mothers.
• Height-<140 cm & BMI > 35 Kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	Time of the first analgesic request

Secondary Outcome Measures

Name	Time	Method
1.Onset of sensory block	2.Onset of motor block

Trial Locations

Locations (1)

Balaji Institute of Surgery, Research and Rehabilitation for Disabled; 🇮🇳 Chittoor, ANDHRA PRADESH, India

Balaji Institute of Surgery, Research and Rehabilitation for Disabled

🇮🇳Chittoor, ANDHRA PRADESH, India

Dr Manoj Sankala

Principal investigator

9701418841

manojmighty@gmail.com