Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

Bristol-Myers Squibb86 enrolled

Overview

The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

ParacetamolDRUG

IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours

PlaceboDRUG

IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Spinal anesth * BMI 10-35 * No pain conditions/concom med may alter pain quantif. Exclusion Criteria: * Other add. surgery * Liver/Renal function altered * coagulation alterations * Respir / Cardiac insufficiency * Agents affecting microsomal syst

Locations (5)

Local Institution

Alcorcón, Spain

Local Institution

Barcelona, Spain

Local Institution

Madrid, Spain

Local Institution

Madrid, Spain

Local Institution

Vizcaya, Spain

Outcomes

Primary Outcomes

24-hour cumulative dose of tramadol

Time frame: 24 hours, defining TO as the start time of the first dose of study drug

Secondary Outcomes

Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs.

Time frame: 24 hours, defining TO as the start time of the first dose of study drug

Data from ClinicalTrials.gov

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