Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Pain Clinical Trial

Official title:

Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01466101
• Other study ID #: STU00025229
• Status: Withdrawn
• Phase: N/A
• First received: April 20, 2010
• Last updated: February 17, 2012
• Start date: January 2011

Study information

• Verified date: February 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo administration
Administration of placebo
• Pregabalin administration
Administration of pregabalin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

References & Publications (10)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1093/bja/aen098. Epub 2008 Apr 29. — View Citation

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

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. Review. — View Citation

Turan A, Karamanlioglu B, Memis 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total hydromorphone consumption	total hydromorphone consumption 24 hours post operatively	24 hours	No
Secondary	Pain Scores postoperative	Post operative pain scores	Post operative period	No