A clinical study to understand the pain relieving effects of drug dexmedetomidine in patients who have undergone below knee trauma surgery
Phase 4
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2017/02/007955
- Lead Sponsor
- Government Medical College Hospital Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1.ASA physical status I and II of both sex.
2.Age between 18 to 65 years.
3. BMI >= 20 to <= 35 kg m-2 .
4.Scheduled for below knee surgery following acute trauma
Exclusion Criteria
1.Patients having history of substance abuse.
2.Patients with coagulopathy and bleeding disorders.
3.Preexisting peripheral neuropathy.
4.Preexisting local infection at the site of block.
5.Pregnant and lactating women.
6.Inability to understand functioning of PCA pump and VAS (Visual Analogue Scale).
7.Contraindication or allergy to study drug ropivacaine, dexmedetomidine and tramadol.
8.Patients having haemodynamic instability.
9.Patients on regular chronic pain management drugs for the last three months.
10.Patients with history of head injury and/or polytrauma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study tramadol-sparing effect of dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided adductor canal block (ACB) and sciatic popliteal block (SPB) following surgery in below knee surgeryTimepoint: At regular interval upto one hour and then <br/ ><br>4 hour <br/ ><br>6 hour <br/ ><br>12 hour <br/ ><br>18 hour <br/ ><br>24 hour <br/ ><br>30 hour <br/ ><br>36 hour <br/ ><br>42 hour <br/ ><br>48 hour
- Secondary Outcome Measures
Name Time Method To study the hemodynamics, <br/ ><br>Visual analogue score at rest and on movement <br/ ><br>Ramsay Sedation Score <br/ ><br>Quadriceps strength test <br/ ><br>planter and dorsiflexion <br/ ><br>sensory analgesia <br/ ><br>rescue analgesia <br/ ><br>adverse effects <br/ ><br>and patient satisfaction score in patients receiving PNB following below knee surgeriesTimepoint: At regular interval upto one hour and then <br/ ><br>4 hour <br/ ><br>6 hour <br/ ><br>12 hour <br/ ><br>18 hour <br/ ><br>24 hour <br/ ><br>30 hour <br/ ><br>36 hour <br/ ><br>42 hour <br/ ><br>48 hour