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Comparison between two drugs (Ketamine and Gabapentin) in patient population undergoing surgery for spine tumours to relieve post-operative pain

A Comparison of Ketamine versus Gabapentin in post-operative pain assessment in patients undergoing spinal neoplasms resection: A prospective, randomized, double blinded Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077067
Enrollment
81
Registered
2024-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: C720- Malignant neoplasm of spinal cord Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Ketamine: Patients with spine neoplasms, meeting the inclusion criteria will be randomly allocated to either of the groups by the computer generated table of random numbers. They will b

Sponsors

Kanika Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. ASA grade I/II/III 3. Patients belonging to either sex 4. Patients planned for elective surgery for spinal tumors 5. Pre-operative motor power of bilateral lower limbs 4+/5

Exclusion criteria

Exclusion criteria: 1. Refusal to consent 2. Patient lost to follow-up/not willing for follow-up 3. Known allergy to study drugs 4. Patients with history of substance abuse/addiction other than smoking 5. Patients already on Tab. Gabapentin 6. Patients with pre-existing significant cardiac, respiratory, hepatic, renal disease 7. Pregnancy 8. Patients planned for mechanical ventilation after surgery

Design outcomes

Primary

MeasureTime frame
To compare Ketamine versus Gabapentin for- 1. Post-operative pain assessment at regular intervals in first 24 hours after surgery using Numeric Rating Scale (NRS)Timepoint: Post extubation- 15th minute 2nd hour 6th hour 12th hour—

Secondary

MeasureTime frame
To compare Ketamine and Gabapentin in terms of- 1. Intra-operative haemodynamic fluctuations 2. Opioid consumption in peri-operative period 3. Requirement of rescue analgesia in post-operative period 4. Adverse effects of study drugs if any 5. Time to first ambulation (hours) 6. Number of hospitalization days 7. Quality of life assessment at the time of hospital discharge and 30 days follow up using EuroQoL questionnaireTimepoint: Intra-operative blood pressure and heart rate monitoring at regular intervals Rest as mentioned above—

Countries

India

Contacts

Public ContactPriyanka Gupta

All India Institute of Medical Sciences, Rishikesh, Uttarakhand

drpriyankagupta84@gmail.com9811894899

Outcome results

None listed

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