The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

Pain, Postoperative Clinical Trial

Official title:

The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00236223
• Other study ID #: SM2-05
• Status: Terminated
• Phase: Phase 4
• First received: October 7, 2005
• Last updated: May 14, 2008
• Start date: October 2005
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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.

Description:

The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for primary total hip replacement,

• Between 55 and 85 years of age,

• ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

• Unable to cooperate

• Does not speak Danish

• Has allergy for drugs used in the trial

• Drug or alcohol abuse

• Epilepsy

• Medically treated diabetes

• Known kidney disease

• Daily use of analgetics

• Apart from NSAID

• Paracetamol or COX2 inhibitors

• Are treated with a antidepressive.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Gabapentin + dexamethasone + ketamine
Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
• Placebo
Matching placebo

Locations

Country	Name	City	State
Denmark	Operations og Anæstesiologisk afd. Y, KAS Glostrup	Glostrup
Denmark	Anæstesiafdelingen, Herning Centralsygehus	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)		0-24h	No
Secondary	Pain score (VAS)= at rest and at mobilisation.		0-24h	No
Secondary	Postoperative Nausea and vomiting.		0-24h	No
Secondary	Dizziness		0-24h	No
Secondary	Sedation		0-24h	No
Secondary	Nightmare and hallucinations.		0-24h	No
Secondary	All measurements are taken at 2,4 and 24 h postoperatively.		0-24h	No