Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations - Full Text View

Sponsored by:	Glostrup University Hospital,Copenhagen
Information provided by:	Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:	NCT00235261

Purpose

Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: 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 and improve the patients pain score after operation.

Condition	Intervention	Phase
Pain Postoperative	Drug: Pregabalin Drug: Dexamethasone	Phase IV

MedlinePlus related topics: Dizziness and Vertigo Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Pregabalin Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement

Further study details as provided by Glostrup University Hospital,Copenhagen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Pain score (VAS) at rest and at mobilisation.
Postoperative nausea and vomiting.
Sedation.
Dizziness
All measurements are taken at 2,4 and 24 h postoperatively

Estimated Enrollment:	120
Study Start Date:	October 2005
Study Completion Date:	June 2007

Detailed Description:

We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for primary total hip replacement in spinal anaesthesia
between the age of 55 and 75,
ASA 1-3, and with
BMI between 18 and 35.

Exclusion Criteria:

are unable to cooperate;
does not speak Danish;
has allergy for drugs used in the trial;
has drug and/or medicine abuse;
epilepsy;
diabetes treated with medicine;
treatment with systemic steroids within 4 weeks prior to the operation;
daily use of antacids;
daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;
known kidney disease;
use of antidepressants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235261

Locations

Denmark, Frederiksborg Amt
Department of anaesthesiology; Hoersholm Sygehus
Hoersholm, Frederiksborg Amt, Denmark, 2970

Sponsors and Collaborators

Glostrup University Hospital,Copenhagen

Investigators

Study Chair:	Ole Mathiesen, MD	Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Principal Investigator:	Lars Steen Jacobsen, MD	Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; Denmark

More Information

Study ID Numbers:	SM3-05
Study First Received:	October 6, 2005
Last Updated:	August 16, 2007
ClinicalTrials.gov Identifier:	NCT00235261
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency; Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital,Copenhagen:

Total hip replacement
Pregablin
Dexamethasone
Multimodal postoperative analgesia.

Study placed in the following topic categories:

Dexamethasone
Pregabalin
Pain
Acetaminophen
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Glucocorticoids
Hormones

Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009