Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

This study has been withdrawn prior to enrollment.
(PI left the institution. No subjects screened or enrolled.)
Sponsor:
Information provided by (Responsible Party):
Christian Altman, Northwestern University
ClinicalTrials.gov Identifier:
NCT01466101
First received: April 20, 2010
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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 Intervention
Pain
Drug: Placebo administration
Drug: Pregabalin administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • total hydromorphone consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    total hydromorphone consumption 24 hours post operatively


Secondary Outcome Measures:
  • Pain Scores postoperative [ Time Frame: Post operative period ] [ Designated as safety issue: No ]
    Post operative pain scores


Enrollment: 0
Study Start Date: January 2011
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466101

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

Publications:

Responsible Party: Christian Altman, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01466101     History of Changes
Other Study ID Numbers: STU00025229
Study First Received: April 20, 2010
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Hysterectomy
Pain
Pregabalin

Additional relevant MeSH terms:
Analgesics
Pregabalin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 20, 2014