Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
NCT ID: NCT01466101
Last Updated: 2012-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Pregabalin administration
Administration of pregabalin
Pregabalin administration
Administration of pregabalin
Placebo
Administration of placebo
Placebo administration
Administration of placebo
Interventions
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Placebo administration
Administration of placebo
Pregabalin administration
Administration of pregabalin
Eligibility Criteria
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Inclusion Criteria
* Age 18-64
* BMI 18-35
* Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
* Gender: Female
* Consent: Obtained
Exclusion Criteria
* 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
18 Years
64 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Christian Altman
Principal Investigator
Principal Investigators
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Christian Altman, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
References
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Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
Tang R, Evans H, Chaput A, Kim C. Multimodal analgesia for hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):377-87. doi: 10.1016/j.ocl.2009.04.001.
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. doi: 10.1097/ACO.0b013e3282effaa7.
Turan A, Karamanlioglu B, Memis D, Usar P, Pamukcu Z, Ture M. The analgesic effects of gabapentin after total abdominal hysterectomy. Anesth Analg. 2004 May;98(5):1370-3, table of contents. doi: 10.1213/01.ane.0000108964.70485.b2.
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. doi: 10.1016/j.pain.2004.10.008.
Jokela R, Ahonen J, Tallgren M, Haanpaa 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. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.
Jokela R, Ahonen J, Tallgren M, Haanpaa 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. doi: 10.1093/bja/aen098. 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. doi: 10.1093/bja/aen244. 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. doi: 10.1007/s11695-009-9944-1. 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. doi: 10.1097/01.anes.0000265161.39932.e8.
Other Identifiers
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STU00025229
Identifier Type: -
Identifier Source: org_study_id
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