A prospective randomized study to compare Intravenous Ibuprofen versus Intravenous Paracetamol in post operative pain management of vaginal hysterectomy patients under spinal anesthesia.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- GMERS Medical College and Hospital Gotri Vadodara
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Total opioid consumption in 24 hours with use of two study drugs
Overview
Brief Summary
This prospective randomized controlled study is designed to compare the efficacy and safety of intravenous ibuprofen versus intravenous paracetamol in the management of postoperative pain in patients undergoing vaginal hysterectomy under spinal anesthesia.
Eligible patients will be randomized into two groups:
Group I (Ibuprofen group): will receive IV ibuprofen 800 mg every 8 hours.
Group P (Paracetamol group): will receive IV paracetamol 1 g every 8 hours.
•SAB using Inj Bupivacaine heavy (0.5%) 3.6 ml + Inj Butorphanol 0.2 mg , to make total volume of 3.8 ml injected into subarachnoid space using 23 Q Quincke’s spinal needle
•Immediately post operatively, a baseline VAS observed.
•Study drug administered 30 mins after shifting the patient to a recovery room.
• VAS Score assessed at 30 min, 60 min, 90 min, 2 hours and there after every 2 hours following the first dose till 24 hours.
• Rescue analgesia in the form of Inj Tramadol 2 mg/kg is given if VAS score more than 4
•T0 is the time of giving the first dose of study drug and the time from T0 to first rescue analgesia will be considered as the total duration of analgesia.
The primary outcome is to compare the total opioid consumption in 24 hours with the use of two study drugs.
The secondary outcomes such as to compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia), assess hemodynamic stability of both drugs and to compare the incidence of adverse events
This study aims to evaluate and compare the analgesic efficacy, duration of pain relief, opioid sparing effect of IV ibuprofen (new formulation) and IV paracetamol in the clinical setting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female patient posted for Vaginal hysterectomy under Spinal anesthesia consenting for participating in this study Patient aged between 35-65 years All elective surgeries of ASA I and II patients.
Exclusion Criteria
- •1.Patient’s refusal 2.History of allergy or hypersensitivity to NSAIDs 3.History of Peptic ulcer or intestinal Inflammatory disease.
- •4.Contraindications for spinal anaesthesia 5.Coagulation disorders 6.Any systemic organ involvement or any other co morbidity.
- •7.Duration of Surgery more than 2 hours.
Outcomes
Primary Outcomes
Total opioid consumption in 24 hours with use of two study drugs
Time Frame: Total opioid consumption in 24 hours with use of two study drugs
Secondary Outcomes
- To Compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia)(To assess hemodynamic stability of both drugs)
Investigators
Dr. Pooja Zala
GMERS Medical college and Hospital, Gotri, Vadodara