Perioperative Administration of Pregabalin for Pain After Mastectomy

• Sponsor: Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00938548
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Pregabalin; Drug: Vitamin Complex (placebo)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Perioperative Administration of Pregabalin for Pain After Mastectomy
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Drug: Vitamin Complex (placebo); Vitamin Complex orally
Experimental: Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later	Drug: Pregabalin; Pregabalin 75 mg orally

Outcome Measures

Primary Outcome Measures

1. Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. [1, 6, 24, 48 hour]

   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.

2. Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. [1, 6, 24, 48 hour]

   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

1. Pain Scores (VNRS) at 1 Week and 1 Month After Operation [1 week, 1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 69 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine and Anesthesia	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00938548
• Other Study ID Numbers: IRB 4-2009-0186
• First Posted: Jul 14, 2009
• Last Update Posted: May 25, 2010
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: mastectomy; pain, postoperative; pregabalin
• Additional relevant MeSH terms: Pain, Postoperative; Pregabalin

Study Results

Participant Flow

Recruitment Details	This study was approved by the Institutional Ethics Committee of Yonsei University Medical Center. Datas were collected between June and December 2009.
Pre-assignment Detail	Of a total of 78 patients assessed for eligibility, 70 subjects received pregabalin or placebo after randomization. Eight patients were excluded because some patients refused to participate and some patients have psychiatric disorder and insulin-dependent DM.

Arm/Group Title	Placebo	Pregabalin
Arm/Group 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
Period Title: Overall Study
STARTED	35	35
COMPLETED	35	35
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Pregabalin	Total
Arm/Group 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	Total of all reporting groups
Overall Participants	35	35	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 97.1%	33 94.3%	67 95.7%
>=65 years	1 2.9%	2 5.7%	3 4.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (8)	51 (9)	50 (8)
Sex: Female, Male (Count of Participants)
Female	35 100%	35 100%	70 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Korea, Republic of	35 100%	35 100%	70 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Pregabalin
Arm/Group 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
Measure Participants	35	35
1 hr	7 (1.8)	5 (2.1)
6 hr	6 (2.1)	5 (2.2)
24 hr	5 (1.7)	3 (1.5)
48 hr	3 (1.8)	2 (1.3)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Pregabalin
Arm/Group 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
Measure Participants	35	35
PONV	4 11.4%	3 8.6%
sedation	8 22.9%	13 37.1%
headache	9 25.7%	5 14.3%
dizziness	12 34.3%	17 48.6%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Pregabalin
Arm/Group 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
Measure Participants	35	35
1 week	2.9 (1.3)	1.4 (0.9)
1 month	1.7 (1.6)	0.6 (0.6)

Adverse Events

Arm/Group Title	Placebo		Pregabalin
Arm/Group 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
All Cause Mortality
	Placebo		Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/35 (51.4%)		19/35 (54.3%)
Gastrointestinal disorders
PONV	4/35 (11.4%)		3/35 (8.6%)
Nervous system disorders
dizziness	12/35 (34.3%)		17/35 (48.6%)
sedation	8/35 (22.9%)		13/35 (37.1%)
headache	9/35 (25.7%)		5/35 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.