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Comparing the analgesic efficiency among paracetamol, ibuprofen and paracetamol-ibuprofen given preoperatively by monitoring vitals intraoperatively and VAS score postoperatively in orthopedic surgeries.

Comparison of analgesic efficacy of pre-emptive paracetamol, ibuprofen and paracetamol-ibuprofen in orthopedic surgeries. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069194
Enrollment
109
Registered
2024-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Paracetamol: Injection 1 gm intravenous given preoperatively 15 mins before induction. Control Intervention1: Ibuprofen: Injection 400 mg intravenously given preoperatively 15 mins befo

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1 ASA class I or II 2 Age from 18 to 70 years either sex 3 Measuring 150 to 180 cm height, with body mass index BMI of 18 to 35 kg per m2 4 Patients undergoing elective and emergency orthopaedic surgeries requiring spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1 All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre existing neurological deficits in lower extremities, unwillingness to give consent. 2 Surgical duration more than 2 hours 3 Sensory blockade inadequate for surgery. 4 Patients having cardiac rhythm abnormalities. 5 History of alcoholism, drug abuse, and psychiatric disorders. 6 History of allergy to any of the study drugs. 7 Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders. 8 Chronic pain patients undergoing treatment with opioid analgesic. 9 Pregnant patients.

Design outcomes

Primary

MeasureTime frame
Pain will be assessed with Visual Analogue Scale between 0 and 10 Timepoint: 1 Pain will be assessed with Visual Analogue Scale between o and 10 at every 15 minutes till 2 hours and then after every 2 hours till 6 hours and then after 12th hour and at 24th hour in ward. 2 Time of onset of T10 sensory block and time to peak sensory block will be noted 3 Time of onset of Bromage 3 motor block will be noted. 4 Time of supplemental analgesia administered

Secondary

MeasureTime frame
1 To assess the haemodynamics intraoperatively & postoperatively. 2 To assess the adverse effects. Timepoint: 1 Haemodynamics like heart rate mean arterial pressure oxygen saturation spo2 will be recorded every 5 minutes during the intraoperative period. Thereafter the parameters will be observed after every 15 minutes till 2 hours postoperatively & thereafter every 2 hours till 6 hours & then at 12th hour & 24th hour postoperatively in ward.

Countries

India

Contacts

Public ContactDr Manpreet Singh

Government Medical College and Hospital

manpreetdawar@gmail.com9646121503

Outcome results

None listed

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