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A clinical trial to study the effect of two drugs, dexmedetomidine and morphine to a local anaesthetic drug ropivacaine compared to using the local anaesthetic ropivacaine alone to reduce post operative pain following spine surgery.

Effects of dexmedetomidine and morphine as adjuvants to ropivacaine in comparison with plain ropivacaine 0.2 % for bilateral multilayer and multilevel myofascial infiltration for postoperative pain relief in patients undergoing elective thoracolumbar spinal surgery. A double-blinded randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048425
Enrollment
66
Registered
2022-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M432- Fusion of spine

Interventions

Intervention1: Comparision of two adjuvants: Group RD will receive 0.2% ropivacaine (38 ml) and 1 mcg/kg ideal body weight of dexmedetomidine (in a volume of 2 ml), at the time of surgical wound closu

Sponsors

Dr Sandeep Dey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) I/II. 2. Elective thoracolumbar spinal fusion surgery. 3. Patients giving written informed consent for study.

Exclusion criteria

Exclusion criteria: 1. Known allergy to study drugs. 2. Presence of severe uncontrolled renal, liver, cerebrovascular or cardiovascular disease. 3. Chronic beta blocker treatment with heart rate or preoperative HR 4. Patients with psychiatric illness, low GCS ( 5. Pregnancy

Design outcomes

Primary

MeasureTime frame
To compare the total opioid consumption in the first 24-hours post-operative period between the groups.Timepoint: At the end of surgery and final evaluation after 1 year.

Secondary

MeasureTime frame
To compare the post operative analgesia (using visual analogue scale) between the groups.Timepoint: At the end of surgery and final evaluation after 1 year.;To compare the side effect profile between the groups.Timepoint: At the end of surgery and final evaluation after 1 year.;To compare the time of the first request for rescue analgesia between the groupsTimepoint: At the end of surgery and final evaluation after 1 year.

Countries

India

Contacts

Public ContactDr Mukesh Mohan Gupta

Paras Hospitals, Gorgaon

docmmg@gmail.com9871174766

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026