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This study has been withdrawn prior to enrollment.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

April 20, 2010
February 17, 2012
January 2011
Not Provided
total hydromorphone consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
total hydromorphone consumption 24 hours post operatively
Same as current
Complete list of historical versions of study NCT01466101 on ClinicalTrials.gov Archive Site
Pain Scores postoperative [ Time Frame: Post operative period ] [ Designated as safety issue: No ]
Post operative pain scores
Same as current
Not Provided
Not Provided
 
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Pain
  • Drug: Placebo administration
    Administration of placebo
  • Drug: Pregabalin administration
    Administration of pregabalin
  • Active Comparator: Pregabalin administration
    Administration of pregabalin
    Intervention: Drug: Pregabalin administration
  • Placebo Comparator: Placebo
    Administration of placebo
    Intervention: Drug: Placebo administration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01466101
STU00025229
No
Christian Altman, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Christian Altman, MD Northwestern University
Northwestern University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP