Clinical trial NCT01466101: Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
Official title: Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Keywords: Hysterectomy
Pain
Pregabalin
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: total hydromorphone consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores postoperative
timeFrame: Post operative period
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Christian Altman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.