Pregabalin and Analgesia After Laparoscopic Cholecystectomy

NCT01321801 | Completed DMC

• 1 other identifier: UHL25872/ 08/17/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.

Conditions

Pain Postoperative

Keywords

Pregabalin; Laparoscopic cholecystectomy; Postoperative pain; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  VAS = visual analoque scale 0-10 mm (0=no pain to 10= worst imaginable pain).Measured on the arrival of the patient to the recovery room(0 hrs), one hour later, and then every eight hours until the completion of 24 hours after operation.

  Every 8 hours

Secondary Outcomes (2)

• Side- effects

  0,1, 8, 16 & 24 hours

• Postoperative opioid consumption

  0,1, 8, 16 & 24 hour

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Preoperative administration of pregabalin 600mg to patients undergo laparoscopic cholecystectomy.Patients receive oral Pregabalin 300 mg the night before the surgery, and another one dose of 300 mg 1 hour prior to surgery

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Preoperative administration of placebo to patients undergo laparoscopic cholecystectomy.Patients receive oral Placebo the night before the surgery, and another one dose 1 hour prior to surgery.

Drug: placebo

Interventions

Pregabalin DRUG

Preoperative administration of pregabalin 600mg

Also known as: Lyrica

Pregabalin

placebo DRUG

Preoperative administration of a matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II

You may not qualify if:

• Renal or hepatic insufficiency
• Alcohol or drugs abuse
• History of chronic pain or daily intake of analgesics
• Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
• Inability of patients to use PCA pump
• History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

University Hospital of Larissa

Larissa, 41100, Greece

Location

Related Publications (14)

• 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.

  PMID: 17507163 BACKGROUND

• White PF, Tufanogullari B, Taylor J, Klein K. The effect of pregabalin on preoperative anxiety and sedation levels: a dose-ranging study. Anesth Analg. 2009 Apr;108(4):1140-5. doi: 10.1213/ane.0b013e31818d40ce.

  PMID: 19299776 BACKGROUND

• Paech MJ, Goy R, Chua S, Scott K, Christmas T, Doherty DA. A randomized, placebo-controlled trial of preoperative oral pregabalin for postoperative pain relief after minor gynecological surgery. Anesth Analg. 2007 Nov;105(5):1449-53, table of contents. doi: 10.1213/01.ane.0000286227.13306.d7.

  PMID: 17959981 BACKGROUND

• Mathiesen O, Rasmussen ML, Dierking G, Lech K, Hilsted KL, Fomsgaard JS, Lose G, Dahl JB. Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial. Acta Anaesthesiol Scand. 2009 Feb;53(2):227-35. doi: 10.1111/j.1399-6576.2008.01821.x. Epub 2008 Dec 6.

  PMID: 19076108 BACKGROUND

• Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.

  PMID: 18653493 BACKGROUND

• Bisgaard T. Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence. Anesthesiology. 2006 Apr;104(4):835-46. doi: 10.1097/00000542-200604000-00030.

  PMID: 16571981 BACKGROUND

• Chang SH, Lee HW, Kim HK, Kim SH, Kim DK. An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. Anesth Analg. 2009 Oct;109(4):1284-6. doi: 10.1213/ane.0b013e3181b4874d. Epub 2009 Jul 29.

  PMID: 19641054 BACKGROUND

• 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.

  PMID: 18716003 BACKGROUND

• 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.

  PMID: 19727980 BACKGROUND

• 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.

  PMID: 18448418 BACKGROUND

• Peng PW, Li C, Farcas E, Haley A, Wong W, Bender J, Chung F. Use of low-dose pregabalin in patients undergoing laparoscopic cholecystectomy. Br J Anaesth. 2010 Aug;105(2):155-61. doi: 10.1093/bja/aeq116. Epub 2010 Jun 25.

  PMID: 20581215 BACKGROUND

• Ittichaikulthol W, Virankabutra T, Kunopart M, Khamhom W, Putarawuthichai P, Rungphet S. Effects of pregabalin on post operative morphine consumption and pain after abdominal hysterectomy with/without salphingo-oophorectomy: a randomized, double-blind trial. J Med Assoc Thai. 2009 Oct;92(10):1318-23.

  PMID: 19845240 BACKGROUND

• Gajraj NM. Pregabalin: its pharmacology and use in pain management. Anesth Analg. 2007 Dec;105(6):1805-15. doi: 10.1213/01.ane.0000287643.13410.5e.

  PMID: 18042886 BACKGROUND

• Sarakatsianou C, Theodorou E, Georgopoulou S, Stamatiou G, Tzovaras G. Effect of pre-emptive pregabalin on pain intensity and postoperative morphine consumption after laparoscopic cholecystectomy. Surg Endosc. 2013 Jul;27(7):2504-11. doi: 10.1007/s00464-012-2769-3. Epub 2013 Jan 24.

  PMID: 23344509 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Chamaidi Sarakatsianou, RN, MSc

  University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

• George Tzovaras, MD

  University Hospital of Larissa

  STUDY CHAIR

• Georgia Stamatiou, MD

  University Hospital of Larissa

  STUDY DIRECTOR

• Elena Theodorou, MD

  University Hospital of Larissa

  STUDY CHAIR

• Stavroula Georgopoulou, MD

  University Hospital of Larissa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN,MSc

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

GR (1)