Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pregabalin
Vitamin Complex (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring thyroidectomy, pain, postoperative, pregabalin
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesia physical status class I & II
- Age ≥ 20 and ≤ 65 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)
Sites / Locations
- Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Pregabalin
Arm Description
Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Outcomes
Primary Outcome Measures
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
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
The 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. We asked patients about sedation, headache, dizziness, blurred vision.
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Secondary Outcome Measures
Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.
we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00905580
Brief Title
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Official Title
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
thyroidectomy, pain, postoperative, pregabalin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later
Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 150 mg orally
Intervention Type
Drug
Intervention Name(s)
Vitamin Complex (placebo)
Intervention Description
Vitamin Complex 150 mg orally
Primary Outcome Measure Information:
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
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
Title
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time Frame
1, 6, 24 & 48 hours
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesia physical status class I & II
Age ≥ 20 and ≤ 65 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 and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20376496
Citation
Kim SY, Jeong JJ, Chung WY, Kim HJ, Nam KH, Shim YH. Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial. Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8.
Results Reference
derived
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Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
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