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: Medical and Surgical,

Registration Number: CTRI/2017/02/007955

Lead Sponsor: Government Medical College Hospital Chandigarh

Brief Summary: | | |

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|Brief Summary

The present study will be conducted in the Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh in collaboration with the department of Orthopaedics, Government Medical College and Hospital, Chandigarh. After approval from the Hospital Ethics Committee and registration with Clinical Trial Registry India, 90 patients of American society of Anesthesiologists (ASA) physical status I &II of either sex, aged between trauma will be enrolled.

Study design- Prospective, randomized, double blind and placebo controlled trial.

The primary outcome measures will be to study tramadol sparing effect in patients receiving dexmedetomidine as adjuvant in adductor canal and sciatic popliteal nerve block in patients undergoing below knee trauma surgeries.

The secondary outcomes will be to study the hemodynamics, VAS at rest and on movement, Ramsay Sedation scale Quadriceps muscle strength, rescue analgesia adverse effects patient satisfaction score, length of hospital stay and follow up at three months (telephonically) in patients receiving adductor canal block and sciatic popliteal nerve block following below knee surgeries.

Sample size was calculated on the basis of pilot cases conducted in the department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh. It was observed that the mean tramadol consumption in the patients receiving ropivacaine in the ACB and SPB (control group) was 106.60 mg with a standard deviation of 37.40 mg. Considering a difference of 30 % in tramadol consumption in study group as compared to control group as statistically significant, with an effective size of 0.34, the required sample size came out to be 27 patients per group at a power of 80%. To compensate for dropouts, we decided to include 30 patients per group. So, the total sample size of our study will be 90 patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.ASA physical status I and II of both sex.
2.Age between 18 to 65 years.
BMI â‰¥ 20 to â‰¤ 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 surgery	At regular interval upto one hour and then \| 4 hour \| 6 hour \| 12 hour \| 18 hour \| 24 hour \| 30 hour \| 36 hour \| 42 hour \| 48 hour

Secondary Outcome Measures

Name	Time	Method
To study the hemodynamics,	Visual analogue score at rest and on movement

Trial Locations

Locations (1): Government Medical College Hospital Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
Government Medical College Hospital Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Dr Vanita Ahuja
Principal investigator
09646121649
vanitaanupam@yahoo.co.in