Pain, PostoperativePhase 4NCT00905580
Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
A Phase 4 study testing Pregabalin in people with Pain, Postoperative, run by Severance Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesia physical status class I \& II
- Age ≥ 20 and ≤ 65 years
- Robot- assisted endoscopic thyroidectomy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
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.
- Conditions
- Pain, Postoperative
- Being tested
- Pregabalin, Vitamin Complex (placebo)
- Keywords
- thyroidectomy, pain, postoperative, pregabalin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 150 mg orally
Vitamin Complex (placebo)Drug
Vitamin Complex 150 mg orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later Receives: Drug: Vitamin Complex (placebo) |
| Pregabalin | Experimental | Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1, 6, 24 & 48 hours
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.
Measured: 1, 6, 24 & 48 hours
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Measured: 1, 6, 24 & 48 hours
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905580
- Sponsor's protocol ID
- IRB 4-2009-0070
- Status last verified
- Oct 2009
- First submitted
- 18 May 2009
- Last updated
- 20 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20376496
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
- ClinicalTrials.gov ID
- NCT00905580
- Acronym / sponsor ID
- IRB 4-2009-0070
- Conditions
- Pain, Postoperative
- Keywords
- thyroidectomy, pain, postoperative, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 May 2009 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Vitamin Complex (placebo)Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later |
| Pregabalin | Experimental | Drug: PregabalinPatients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesia physical status class I \& II
- Age ≥ 20 and ≤ 65 years
- Robot- assisted endoscopic thyroidectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPregabalin 150 mg orally | Drug | Pregabalin |
| Vitamin Complex (placebo)Vitamin Complex 150 mg orally | Drug | Placebo |
Primary outcome
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
Time frame: 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
The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
Time frame: 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.
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time frame: 1, 6, 24 & 48 hours
1 secondary outcome
Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20376496Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Pain, Postoperative, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. (time frame: 1, 6, 24 & 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.