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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209495

Enrollment

130

Registered

2005-09-21

Start date

2005-06-30

Completion date

2008-02-29

Last updated

2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Abdominal hysterectomy, Pregabalin, Dexamethasone, Multimodal postoperative analgesia

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.

Interventions

DRUGPregabalin; Dexamethasone

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026