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To compare two variety modes of pain decreasing methods on well being in patients undergoing backbone operation.

Epidural morphine and ketamine versus intravenous morphine and ketamine on postoperative quality of recovery(QoR) in patients undergoing transforaminal lumbar interbody fusion:A single blinded randomised controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022513
Enrollment
40
Registered
2019-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: - Health Condition 2: G55- Nerve root and plexus compressionsin diseases classified elsewhere

Interventions

Intervention1: RCT: Epidural Inj .Morphine 8 mg, Ketamine 60 mg will be diluted upto 50 ml in a CADD pump and will be delivered at 1 ml/hr for 48 hours. Control Intervention1: RCT: PCA through CADD pu

Sponsors

Institutional Review Board
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA grade I and II 2.Patients undergoing Transforaminal Lumbar Interbody fusion. 3.Normal renal function.

Exclusion criteria

Exclusion criteria: 1.ASA III and IV 2.BMI >30 3. Impaired renal function. 4.Intraoperative csf leak 5.Previous surgical procedures in lumbo sacral region 6.Patients with psychiatric illness. 7.Obstructive sleep apnoea.

Design outcomes

Primary

MeasureTime frame
To compare the Quality of recovery score between the two groups of patients using QoR 15 Score.Timepoint: Primary investigator will assess the Quality of recovery at the end of 48 hours after operation in the ward.

Secondary

MeasureTime frame
1. To compare the analgesic efficacy of the two techniques using Numeric rating scale at movement. 2.Patient satisfaction score (0-10). 3.Time of ambulation 4.Length of hospital stay 5. Sedation score, respiratory rate,Ponv,pruritus 6.Time of receiving first rescue analgesia for breakthrough pain.Timepoint: 1. In the post anesthesia care unit by recovery staff at intervals of half an hour till discharge from recovery room . 2 Post operative ward -.Pain nurse and ward staff will asess at the arrival to post operative ward, at 2 hrs, 6 hrs,12 hrs,24 hrs,36 hrs,48 hrs. 3. Primary investigator will assess at end of 24 hrs and 48 hours after suggery.

Countries

India

Contacts

Public ContactDrRamamani mariappan

CHRISTIAN MEDICAL COLLEGE

ramamani@cmcvellore.ac.in9443753184

Outcome results

None listed

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