Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

• Sponsor: Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00905580
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 24.5

Study Details

Study Description

Brief Summary

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy 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 the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months 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: 99 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 Robot-assisted Endoscopic Thyroidectomy
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later	Drug: Vitamin Complex (placebo); Vitamin Complex 150 mg orally
Experimental: Pregabalin Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later	Drug: Pregabalin; Pregabalin 150 mg orally

Outcome Measures

Primary Outcome Measures

1. Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. [1, 6, 24 & 48 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 means no pain at all, and 10 represents the worst pain imaginable

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

   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. We asked patients about sedation, headache, dizziness, blurred vision.

3. Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively [1, 6, 24 & 48 hours]

Secondary Outcome Measures

1. Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. [3 months]

   we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. American Society of Anesthesia physical status class I & II

2. Age ≥ 20 and ≤ 65 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 and Pain Research Institute, Yonsei University College of Medicine	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: NCT00905580
• Other Study ID Numbers: IRB 4-2009-0070
• First Posted: May 20, 2009
• Last Update Posted: Jan 20, 2010
• Last Verified: Oct 1, 2009

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

Study Results

Participant Flow

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	49	50
COMPLETED	47	47
NOT COMPLETED	2	3

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	49	50	99
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 100%	50 100%	99 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.5 (9.5)	38.0 (8.2)	38.2 (8.9)
Sex: Female, Male (Count of Participants)
Female	46 93.9%	48 96%	94 94.9%
Male	3 6.1%	2 4%	5 5.1%
Region of Enrollment (participants) [Number]
Korea, Republic of	49 100%	50 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
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 means no pain at all, and 10 represents the worst pain imaginable
Time Frame	1, 6, 24 & 48 hours

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	47	47
1 Hour	6	6
6 Hour	3	2
24 Hour	2	1
48 Hour	2	1

2. Primary Outcome

Title	The 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. We asked patients about sedation, headache, dizziness, blurred vision.
Time Frame	1, 6, 24 & 48 hours

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	47	47
PONV	10 20.4%	7 14%
headache	11 22.4%	8 16%
dizziness	6 12.2%	14 28%
sedation	1 2%	6 12%
blurred vision	0 0%	3 6%

3. Secondary Outcome

Title	Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.
Description	we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.
Time Frame	3 months

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	47	47
Number [participants]	13 26.5%	10 20%

4. Primary Outcome

Title	Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time Frame	1, 6, 24 & 48 hours

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	47	47
0-1 hour	31 63.3%	26 52%
1-6 hour	17 34.7%	7 14%
6 - 24 hour	15 30.6%	2 4%
24 - 48 hour	7 14.3%	1 2%

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	0/47 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Pregabalin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/47 (12.8%)		21/47 (44.7%)
General disorders
Sedation	1/47 (2.1%)	1	6/47 (12.8%)	6
Dizziness	6/47 (12.8%)	6	14/47 (29.8%)	14
Blurred vision	0/47 (0%)	0	3/47 (6.4%)	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.