Perioperative Administration of Pregabalin for Pain After Mastectomy

NCT00938548 | Completed Phase 4 Results DMC

• 1 other identifier: IRB 4-2009-0186
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.

Conditions

Pain, Postoperative

Keywords

mastectomy; pain, postoperative; pregabalin

Outcome Measures

Primary Outcomes (2)

• Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.

  Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.

  1, 6, 24, 48 hour

• Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.

  Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.

  1, 6, 24, 48 hour

Secondary Outcomes (1)

• Pain Scores (VNRS) at 1 Week and 1 Month After Operation

  1 week, 1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later

Drug: Vitamin Complex (placebo)

Pregabalin

EXPERIMENTAL

Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later

Drug: Pregabalin

Interventions

Pregabalin DRUG

Pregabalin 75 mg orally

Pregabalin

Vitamin Complex (placebo) DRUG

Vitamin Complex orally

Placebo

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesia physical status class I \& II
• Age \> 20 and \< 70 years
• Robot- assisted endoscopic thyroidectomy

You may not qualify if:

• Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
• Body mass index ≥ 40 kg/m2
• History of seizure disorder
• Current therapy with pregabalin, gabapentin, or any opioid
• Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
• Insulin-dependent diabetes mellitus
• Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Kim SY, Song JW, Park B, Park S, An YJ, Shim YH. Pregabalin reduces post-operative pain after mastectomy: a double-blind, randomized, placebo-controlled study. Acta Anaesthesiol Scand. 2011 Mar;55(3):290-6. doi: 10.1111/j.1399-6576.2010.02374.x.

  PMID: 21288209 DERIVED

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

Results Point of Contact

• Title: Dr. So Yeon Kim
• Organization: Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Department of surgery, Yonsei University College of Medicine

kimsy326@hanmail.net

82-2-2227-3642

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 25, 2010
• Results First Posted: May 14, 2010

Record last verified: 2009-07

Locations

KR (1)