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Genotype effect on Chest surgery

Multi-modal pre-emptive analgesia with pre-gabalin and naproxen in thoracotomy surgeries and its effect on comt genotype

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/043800
Enrollment
78
Registered
2022-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Assessment of intra-operative hemodynamic stability and post-operative safety and efficacy : 2-8hrs Control Intervention1: NA: NA

Sponsors

Department of Anaesthesiology
Lead Sponsor
Department of Anaesthesiology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: both sexes; aged 18 to 70 years old; ASA I and II normal renal function with creatinine clearance >30 mL/min.

Exclusion criteria

Exclusion criteria: (I) previous administration of antidepressants, anticonvulsants, or opioids before surgery; (II) serious medical conditions (uncontrolled heart, lung, liver or kidney disease or diabetes); (III) a history of angioedema; (IV) pregnant or nursing; (V) problematic in receiving epidural anaesthesia (spinal deformity, or previous anticoagulation therapy).

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the to investigate the efficacy of pre-emptive analgesia comprised of pre-gabalin versus naproxen in thoracotomy while secondary outcome will be to find out the effects of the COMT gene on modulating pain and its association in thoracotomy along with Assessment of intra-operative hemodynamic stability and post-operative safety and efficacy Timepoint: 48 hrs

Secondary

MeasureTime frame
Patients will be asked to rate their pain (NRS) for the previous 24 hours and their sleep interference rate (SIR) during the previous night, and circled numbers which best described on an 11-point scale, where 0 indicated no pain or sleep interference and 10 will be the worst possible pain or the greatest sleep interference. The NRS and SIR will be assessed on the morning of the 1st, 3rd and 5th day after surgery. Each patient will be visited by a trained questioner who will be blinded to the treatment groups and instructed to fill out the evaluation form.Timepoint: 4HRS

Countries

India

Contacts

Public ContactProf Rajni Gupta

King Georges Medical University Lucknow

rgkgmu@gmail.com

Outcome results

None listed

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