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

• Sponsor: Glostrup University Hospital, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00209495
• Collaborator: (none)
• Enrollment: 130
• Locations: 2
• Arms: 3
• Duration (Months): 32
• Patients Per Site: 65
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Pregabalin; Dexamethasone	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A	Drug: Pregabalin; Dexamethasone; Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: B Pregabalin	Drug: Pregabalin; Dexamethasone; Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: C Pregabalin + dexamethasone	Drug: Pregabalin; Dexamethasone; Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Outcome Measures

Primary Outcome Measures

1. 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

1. Pain Score (VAS) at rest and at mobilisation. [0 - 24h]

2. Postoperative nausea and vomiting. [0 - 24h]

3. Sedation. [0 - 24h]

4. Dizziness. [0 - 24h]

5. All measurements are taken at 2, 4 and 24 h postoperatively. [0 - 24h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Operations og Anæstesiologisk afd. Y, KAS Glostrup	Glostrup	Copenhagen	Denmark	2600
2	Herning Centralsygehus	Herning		Denmark	7400

Sponsors and Collaborators

• Glostrup University Hospital, Copenhagen

Investigators

• Principal Investigator: Ole Mathiesen, MD, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00209495
• Other Study ID Numbers: SM1-04
• First Posted: Sep 21, 2005
• Last Update Posted: Feb 29, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Abdominal hysterectomy; Pregabalin; Dexamethasone; Multimodal postoperative analgesia
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Pregabalin

Study Results

No Results Posted as of Feb 29, 2008