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This study has been withdrawn prior to enrollment.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

History of Changes

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:

MedlinePlus related topics: Hysterectomy

Drug Information available for: Pregabalin

U.S. FDA Resources

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:

Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North America. 2005 Mar;23(1):185-202. Review.

Tang R, Evans H, Chaput A, Kim C. Multimodal analgesia for hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):377-87. Review.

Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. Review.

Turan A, Karamanlio?lu B, Memi? D, Usar P, Pamukçu Z, Türe M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents.

Gilron I, Orr E, Tu D, O'Neill JP, Zamora JE, Bell AC. A placebo-controlled randomized clinical trial of perioperative administration of gabapentin, rofecoxib and their combination for spontaneous and movement-evoked pain after abdominal hysterectomy. Pain. 2005 Jan;113(1-2):191-200.

Jokela R, Ahonen J, Tallgren M, Haanpää M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. Epub 2007 May 15.

Jokela R, Ahonen J, Tallgren M, Haanpää M, Korttila K. Premedication with pregabalin 75 or 150 mg with ibuprofen to control pain after day-case gynaecological laparoscopic surgery. Br J Anaesth. 2008 Jun;100(6):834-40. Epub 2008 Apr 29.

Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. Epub 2008 Aug 20.

Cabrera Schulmeyer MC, de la Maza J, Ovalle C, Farias C, Vives I. Analgesic effects of a single preoperative dose of pregabalin after laparoscopic sleeve gastrectomy. Obes Surg. 2010 Dec;20(12):1678-81. Epub 2009 Aug 29.

Brandsborg B, Nikolajsen L, Hansen CT, Kehlet H, Jensen TS. Risk factors for chronic pain after hysterectomy: a nationwide questionnaire and database study. Anesthesiology. 2007 May;106(5):1003-12.

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 May 21, 2013

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