Trial Outcomes & Findings for Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy (NCT NCT00905580)

NCT ID: NCT00905580

Last Updated: 2010-01-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 99 participants
• Primary outcome timeframe: 1, 6, 24 & 48 hours
• Results posted on: 2010-01-20

Participant Flow

Participant milestones

Measure	Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Overall Study STARTED	49	50
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=49 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=50 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	38.5 years STANDARD_DEVIATION 9.5 • n=5 Participants	38.0 years STANDARD_DEVIATION 8.2 • n=7 Participants	38.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Korea, Republic of	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=47 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=47 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. 1 Hour	6 VNRS Interval 5.0 to 8.0	6 VNRS Interval 4.0 to 8.0
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. 6 Hour	3 VNRS Interval 2.0 to 4.0	2 VNRS Interval 1.0 to 3.0
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. 24 Hour	2 VNRS Interval 1.0 to 3.0	1 VNRS Interval 1.0 to 2.0
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. 48 Hour	2 VNRS Interval 1.0 to 2.0	1 VNRS Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=47 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=47 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. PONV	10 participants	7 participants
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. headache	11 participants	8 participants
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. dizziness	6 participants	14 participants
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. sedation	1 participants	6 participants
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. blurred vision	0 participants	3 participants

PRIMARY outcome

Timeframe: 1, 6, 24 & 48 hours

Outcome measures

Measure	Placebo n=47 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=47 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively 24 - 48 hour	7 participants	1 participants
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively 0-1 hour	31 participants	26 participants
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively 1-6 hour	17 participants	7 participants
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively 6 - 24 hour	15 participants	2 participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Placebo n=47 Participants Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=47 Participants Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.	13 participants	10 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Pregabalin

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=47 participants at risk Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later	Pregabalin n=47 participants at risk Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
General disorders Sedation	2.1% 1/47 • Number of events 1	12.8% 6/47 • Number of events 6
General disorders Dizziness	12.8% 6/47 • Number of events 6	29.8% 14/47 • Number of events 14
General disorders Blurred vision	0.00% 0/47	6.4% 3/47 • Number of events 3

Additional Information

Dr. So Yeon Kim

Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Department of surgery, Yonsei University College of Medicine

Phone: 82-2-2227-3642

Email: kimsy326@hanmail.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place