Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Pregabalin; Dexamethasone

• Registration Number: NCT00209495
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: 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.

Detailed Description

Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-11
• Status Verified: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-28
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
• BMI between 18-32.

Exclusion Criteria

Patients who:

• Are unable to cooperate
• Has cancer ovarian
• Does not speak Danish
• Has allergy for drugs used in the trial
• Has drug and medicine abuse
• Epilepsy
• Diabetes treated with medicine
• Chronic pain condition
• Daily use of antacids or analgesic
• Known kidney disease
• Use of antidepressive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pregabalin; Dexamethasone	-
B	Pregabalin; Dexamethasone	Pregabalin
C	Pregabalin; Dexamethasone	Pregabalin + dexamethasone

Primary Outcome Measures

Name	Time	Method
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)	0 - 24h

Secondary Outcome Measures

Name	Time	Method
Pain Score (VAS) at rest and at mobilisation.	0 - 24h
Postoperative nausea and vomiting.	0 - 24h
Sedation.	0 - 24h
Dizziness.	0 - 24h
All measurements are taken at 2, 4 and 24 h postoperatively.	0 - 24h

Trial Locations

Locations (2)

Herning Centralsygehus; 🇩🇰 Herning, Denmark

Operations og Anæstesiologisk afd. Y, KAS Glostrup; 🇩🇰 Glostrup, Copenhagen, Denmark