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

This study has been completed.
Information provided by:
Glostrup University Hospital, Copenhagen Identifier:
First received: September 13, 2005
Last updated: February 28, 2008
Last verified: February 2008
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.

Condition Intervention Phase
Pain, Postoperative
Drug: Pregabalin; Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Abdominal Hysterectomy.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA) [ Time Frame: 0 - 24h ]

Secondary Outcome Measures:
  • Pain Score (VAS) at rest and at mobilisation. [ Time Frame: 0 - 24h ]
  • Postoperative nausea and vomiting. [ Time Frame: 0 - 24h ]
  • Sedation. [ Time Frame: 0 - 24h ]
  • Dizziness. [ Time Frame: 0 - 24h ]
  • All measurements are taken at 2, 4 and 24 h postoperatively. [ Time Frame: 0 - 24h ]

Enrollment: 130
Study Start Date: June 2005
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: B
Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: C
Pregabalin + dexamethasone
Drug: Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Detailed Description:
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00209495

Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup, Copenhagen, Denmark, 2600
Herning Centralsygehus
Herning, Denmark, 7400
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
  More Information Identifier: NCT00209495     History of Changes
Other Study ID Numbers: SM1-04
Study First Received: September 13, 2005
Last Updated: February 28, 2008

Keywords provided by Glostrup University Hospital, Copenhagen:
Abdominal hysterectomy
Multimodal postoperative analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Anticonvulsants processed this record on April 26, 2017