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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014