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

Glostrup University Hospital, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Pregabalin; Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00209495

SM1-04

Details and patient eligibility

About

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.

Full description

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

Enrollment: 130 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Pregabalin; Dexamethasone

B

Experimental group

Description:

Pregabalin

Treatment:

Drug: Pregabalin; Dexamethasone

C

Experimental group

Description:

Pregabalin + dexamethasone

Treatment:

Drug: Pregabalin; Dexamethasone