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

Primary Purpose

Pain, Postoperative

Status

Terminated

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Gabapentin + dexamethasone + ketamine

Placebo

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Primary hip replacement, Gabapentin, Dexamethasone, Ketamine, Multimodal postoperative analgesia.

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Operations og Anæstesiologisk afd. Y, KAS Glostrup
Anæstesiafdelingen, Herning Centralsygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)

Secondary Outcome Measures

Pain score (VAS)= at rest and at mobilisation.

Postoperative Nausea and vomiting.

Dizziness

Sedation

Nightmare and hallucinations.

All measurements are taken at 2,4 and 24 h postoperatively.

Full Information

NCT ID

NCT00236223

First Posted

October 7, 2005

Last Updated

May 14, 2008

Sponsor

Glostrup University Hospital, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00236223

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Terminated

Why Stopped

Structural changes that stopped the type of operations used in the study

Study Start Date

October 2005 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Primary hip replacement, Gabapentin, Dexamethasone, Ketamine, Multimodal postoperative analgesia.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Gabapentin + dexamethasone + ketamine

Other Intervention Name(s)

Anti-hyperalgesics, Postoperative pain

Intervention Description

Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)

Time Frame

0-24h

Secondary Outcome Measure Information:

Title

Pain score (VAS)= at rest and at mobilisation.

Time Frame

0-24h

Title

Postoperative Nausea and vomiting.

Time Frame

0-24h

Title

Dizziness

Time Frame

0-24h

Title

Sedation

Time Frame

0-24h

Title

Nightmare and hallucinations.

Time Frame

0-24h

Title

All measurements are taken at 2,4 and 24 h postoperatively.

Time Frame

0-24h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole Mathiesen, MD

Organizational Affiliation

Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Operations og Anæstesiologisk afd. Y, KAS Glostrup

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Anæstesiafdelingen, Herning Centralsygehus

City

Herning

ZIP/Postal Code

7400

Country

Denmark

12. IPD Sharing Statement

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

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