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This study has been withdrawn prior to enrollment.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.)
Information provided by (Responsible Party):
Christian Altman, Northwestern University Identifier:
First received: April 20, 2010
Last updated: February 17, 2012
Last verified: February 2012
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
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


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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


  • 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 identifier: NCT01466101

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


Responsible Party: Christian Altman, Principal Investigator, Northwestern University 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:

Additional relevant MeSH terms:
Anti-Anxiety Agents
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents processed this record on May 24, 2016