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Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01466101
Recruitment Status : Withdrawn (PI left the institution. No subjects screened or enrolled.)
First Posted : November 7, 2011
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Christian Altman, Northwestern University

Brief Summary:
Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.

Condition or disease Intervention/treatment
Pain Drug: Placebo administration Drug: Pregabalin administration

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
Study Start Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pregabalin administration
Administration of pregabalin
Drug: Pregabalin administration
Administration of pregabalin
Placebo Comparator: Placebo
Administration of placebo
Drug: Placebo administration
Administration of placebo



Primary Outcome Measures :
  1. total hydromorphone consumption [ Time Frame: 24 hours ]
    total hydromorphone consumption 24 hours post operatively


Secondary Outcome Measures :
  1. Pain Scores postoperative [ Time Frame: Post operative period ]
    Post operative pain scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Physical Status 1-2
  • Age 18-64
  • BMI 18-35
  • Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
  • Gender: Female
  • Consent: Obtained

Exclusion Criteria:

  • Patient refusal
  • Allergy to study medication(s)
  • Preoperative use of gabapentinoids
  • Preoperative use of anticonvulsants
  • Daily use of analgesics
  • Hepatic disease
  • Renal insufficiency (Cr >2.0)
  • Alcohol or drug abuse
  • Pregnancy
  • Language: Non-English speaking
  • Patient expected to remain intubated after procedure

Dropout:

  • Patient request
  • Surgeon request
  • Allergic reaction to pregabalin
  • Surgical procedure significantly altered from scheduled procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466101


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Christian Altman, MD Northwestern University

Publications:

Responsible Party: Christian Altman, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01466101     History of Changes
Other Study ID Numbers: STU00025229
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Christian Altman, Northwestern University:
Hysterectomy
Pain
Pregabalin

Additional relevant MeSH terms:
Analgesics
Pregabalin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs