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Perioperative Administration of Pregabalin for Pain After Mastectomy

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin
Vitamin Complex (placebo)
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring mastectomy, pain, postoperative, pregabalin

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesia physical status class I & II
  2. Age > 20 and < 70 years
  3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine and Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Pregabalin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2009
Last Updated
May 17, 2010
Sponsor
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00938548
Brief Title
Perioperative Administration of Pregabalin for Pain After Mastectomy
Official Title
Perioperative Administration of Pregabalin for Pain After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
mastectomy, pain, postoperative, pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 75 mg orally
Intervention Type
Drug
Intervention Name(s)
Vitamin Complex (placebo)
Intervention Description
Vitamin Complex orally
Primary Outcome Measure Information:
Title
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
Description
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.
Time Frame
1, 6, 24, 48 hour
Title
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
Description
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.
Time Frame
1, 6, 24, 48 hour
Secondary Outcome Measure Information:
Title
Pain Scores (VNRS) at 1 Week and 1 Month After Operation
Description
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.
Time Frame
1 week, 1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesia physical status class I & II Age > 20 and < 70 years Robot- assisted endoscopic thyroidectomy Exclusion Criteria: 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)
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine and Anesthesia
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21288209
Citation
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.
Results Reference
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Perioperative Administration of Pregabalin for Pain After Mastectomy

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