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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00236223

Enrollment

Registered

2005-10-12

Start date

2005-10-31

Completion date

2008-05-31

Last updated

2008-05-15

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

Conditions

Pain, Postoperative

Keywords

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

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.

Interventions

DRUGGabapentin + dexamethasone + ketamine

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

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Postoperative Nausea and vomiting.	0-24h
Dizziness	0-24h
Pain score (VAS)= at rest and at mobilisation.	0-24h
Nightmare and hallucinations.	0-24h
All measurements are taken at 2,4 and 24 h postoperatively.	0-24h
Sedation	0-24h

Countries

Denmark

Outcome results

None listed

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