Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

NCT ID: NCT01466101

Last Updated: 2012-02-20

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pregabalin administration

Administration of pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin administration

Intervention Type DRUG

Administration of pregabalin

Placebo

Administration of placebo

Group Type PLACEBO_COMPARATOR

Placebo administration

Intervention Type DRUG

Administration of placebo

Interventions

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Placebo administration

Administration of placebo

Intervention Type DRUG

Pregabalin administration

Administration of pregabalin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Christian Altman

Principal Investigator

Responsibility Role 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.

Reference Type BACKGROUND
PMID: 15763418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19576406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17873599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15105217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15621380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17507163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18448418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18716003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19727980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17457133 (View on PubMed)

Other Identifiers

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STU00025229

Identifier Type: -

Identifier Source: org_study_id

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