Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)
Study Overview
Brief Summary
Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.
Detailed Description
We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for primary total hip replacement in spinal anaesthesia
- •between the age of 55 and 75,
- •ASA 1-3, and with
- •BMI between 18 and 35.
Exclusion Criteria
- •are unable to cooperate;
- •does not speak Danish;
- •has allergy for drugs used in the trial;
- •has drug and/or medicine abuse;
- •epilepsy;
- •diabetes treated with medicine;
- •treatment with systemic steroids within 4 weeks prior to the operation;
- •daily use of antacids;
- •daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;
- •known kidney disease;
- •use of antidepressants
Outcomes
Primary Outcomes
The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)
Secondary Outcomes
- Pain score (VAS) at rest and at mobilisation.
- Postoperative nausea and vomiting.
- Sedation.
- Dizziness
- All measurements are taken at 2,4 and 24 h postoperatively