Analgetic and Anxiolytic Effect of Preoperative Pregabalin

NCT00353704 | Completed Phase 4 Results

• 1 other identifier: 2005-003229-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of oral pregabalin 150 mg as premedication reduces anxiety prior to anaesthesia in these patients.

Conditions

Intervertebral Disk Displacement; Disk Prolapse

Keywords

Intervertebral disk displacement; disk prolapse; pregabalin

Outcome Measures

Primary Outcomes (1)

• Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)

  The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.

  120 minutes after surgery

Secondary Outcomes (1)

• Morphine (Opioid) Consumption Cumulated

  240 minutes

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

150 mg Pregabalin per orally about one hour before surgery

Drug: pregabalin; Drug: morphine

Placebo

PLACEBO COMPARATOR

One capsule of saccharose (placebo) was administered orally about one hour before surgery.

Drug: Placebo; Drug: morphine

Interventions

pregabalin DRUG

capsule 150 mg x 1 per orally one hour before surgery

Pregabalin

Placebo DRUG

One capsule of saccharose (placebo) was administered about one hour before surgery

Placebo

morphine DRUG

All patients were equipped with a PCA (patient controlled analgesia) for 24 hours after surgery. The sum of morphine used was registered (milligram).

Placebo; Pregabalin

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of disc prolapse
• Age 18+
• ASA (American Association in Anesthesiology) I-III
• written consent

You may not qualify if:

• Age \< 18
• ASA \> III
• liver failure
• renal failure
• allergic reaction against gabapentin and/or pregabalin
• pregnancy

Sponsors & Collaborators

• Asker & Baerum Hospital: lead

Study Sites (1)

Asker and Baerum Hospital

Rud, 1309, Norway

Location

Related Publications (4)

• Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.

  PMID: 8346839 BACKGROUND

• Menigaux C, Adam F, Guignard B, Sessler DI, Chauvin M. Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery. Anesth Analg. 2005 May;100(5):1394-1399. doi: 10.1213/01.ANE.0000152010.74739.B8.

  PMID: 15845693 BACKGROUND

• Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.

  PMID: 12218520 BACKGROUND

• Spreng UJ, Dahl V, Raeder J. Effect of a single dose of pregabalin on post-operative pain and pre-operative anxiety in patients undergoing discectomy. Acta Anaesthesiol Scand. 2011 May;55(5):571-6. doi: 10.1111/j.1399-6576.2011.02410.x. Epub 2011 Mar 8.

  PMID: 21385158 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Pregabalin; Morphine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Ulrich J Spreng
• Organization: Baerum Hospital

ulispreng@hotmail.com

004798499184

Study Officials

• Ulrich J Spreng, Dr. med.

  Asker and Baerum Hospital, Norway

  PRINCIPAL INVESTIGATOR

• Vegard Dahl, Dr. med.

  Asker and Baerum Hospital, Norway

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2006
• First Posted: July 19, 2006
• Study Start: November 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2010
• Last Updated: July 20, 2011
• Results First Posted: July 20, 2011

Record last verified: 2011-07

Locations

NO (1)