Skip to content

Effect of adding Ketamine (in low dose) to infusion of Tramadol in a pump controlled by patient himself/herself,on pain after major lumbar spine operations

Effect of adding low dose Ketamine to Tramadol infusion in PCA (Patient Controlled Analgesia) pump on post-operative pain following major lumbar spine surgeries :A prospective observational study - PCA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008555
Enrollment
40
Registered
2017-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients aged 18 to 65 years with ASA physical status I, II or III to be operated for major lumbar spine disease or fracture

Interventions

Intervention1: Group TK(Tramadol with Ketamine Group): In Group TK,loading dose of inj. Tramadol 0.5 mg/kg + inj. Ketamine 0.5 mg/kg will be given i.v. followed by infusion of mixture at the rate of 0

Sponsors

Dr Yuvrajsinh Manharsinh Chauhan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years to 65 years 2.ASA physical status I, II, or III 3.Patients to be operated for major lumbar spine disease or fracture

Exclusion criteria

Exclusion criteria: 1. Allergy to study drug 2. Inability to use PCA pump 3. Long term use of opioid drug 4. History of chronic pain 5. Hepatic dysfunction 6. Renal dysfunction 7. Ischemic heart disease or heart block 8. Respiratory disease 9. Patients on antidepressants 10. History of post operative nausea and vomiting 11. History of motion sickness

Design outcomes

Primary

MeasureTime frame
Primary Aims: 1. To assess effect on Pain Score 2. To assess requirement of rescue analgesics Timepoint: Postoperatively total number of demands & good demands(beyond locking period) will be recorded in PCA pump. Need for rescue analgesic & side effects if any will be recorded at 1hr,2hrs,4hrs,8hrs,12hrs,16hrs & 24 hrs postoperatively.

Secondary

MeasureTime frame
Secondary Aims: 1. To assess side effects 2 . To assess postoperative Satisfaction Score Timepoint: Four Grade Score: (to assess severity of side effects) 0 â?? None 1- Mild 2- Discomfort 3- Worst, requiring rescue medication Patient Satisfaction Scale: Poor Good Excellent

Countries

India

Contacts

Public ContactDr Yuvrajsinh Manharsinh Chauhan

Government medical college & New civil hospital,Surat

dr26hemanginisurat@gmail.com9909663007

Outcome results

None listed

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