ThyroidectomyNCT02577068
Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy
A study testing Nefopam and Propacetamol in people with Thyroidectomy and Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroidectomy, Pain
- What is being tested?
- Nefopam and Propacetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2015to 23 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who undergone open thyroidectomy
- 20~70 years old
- ASA I~III
Who cannot join
- hypersensitivity on Nefopam and Propacetamol
- Liver failure, chronic alcohol addiction
- severe hemolytic anemia, chronic nutrition deficiency
- history of seizure
- MI, MAO inhibitor
- pregnant, breast-feeding
- foreigners
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.
- Conditions
- Thyroidectomy, Pain
- Being tested
- Nefopam, Propacetamol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.
PropacetamolDrug
Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.
| Study group | Role | What they receive |
|---|---|---|
| nefopam group | Active comparator | Not described Receives: Drug: Nefopam |
| propacetamol group | Active comparator | Not described Receives: Drug: Propacetamol |
| nefopam and propacetamol group | Experimental | Not described Receives: Drug: Nefopam; Drug: Propacetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score on wound site and posterior neck
Patients' subject pain score through VAS on the surgery wound site and posterior neck.
Measured: one hour after the surgery
Secondary outcomes (5)
Additional pain rescue drug
how much of pain rescue drugs taken besides PCA
Measured: for postop. 24hrs.
Postoperative nausea and vomiting
nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none)
Measured: for postop. 24hrs.
Patient satisfaction
Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction)
Measured: for postop. 24hrs.
Chronic pain and neurogenic pain
Neuropathic pain diagnostic questionnaire(DN 4) :
The DN4 questionnaire consists of a total of 10 items grouped in 4 sections. The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10. All questions are related to pain which is the claim for current medical consultation.
Measured: three month after the surgery.
acute VAS on wound site and posterior neck
VAS for patients' subject pain scor
Measured: postop. 24hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start15 Nov 2015
- Primary completion23 Aug 2016
- Study completion23 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577068
- Sponsor's protocol ID
- 4-2015-0746
- Status last verified
- Feb 2019
- First submitted
- 6 Oct 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Han DW, Koo BN, Chung WY, Park CS, Kim SY, Palmer PP, Kim KJ. Preoperative greater occipital nerve block in total thyroidectomy patients can reduce postoperative occipital headache and posterior neck pain. Thyroid. 2006 Jun;16(6):599-603. doi: 10.1089/thy.2006.16.599.
PubMed 16839262
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy
- ClinicalTrials.gov ID
- NCT02577068
- Acronym / sponsor ID
- 4-2015-0746
- Conditions
- Thyroidectomy, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Nov 2015
- Primary completion
- 23 Aug 2016 (actual)
- Study completion
- 23 Aug 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nefopam group | Active comparator | Drug: Nefopam |
| propacetamol group | Active comparator | Drug: Propacetamol |
| nefopam and propacetamol group | Experimental | Drug: Nefopam, Drug: Propacetamol |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient who undergone open thyroidectomy
- 20~70 years old
- ASA I~III
Key exclusion criteria (7 listed)
- hypersensitivity on Nefopam and Propacetamol
- Liver failure, chronic alcohol addiction
- severe hemolytic anemia, chronic nutrition deficiency
- history of seizure
- MI, MAO inhibitor
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 |
|---|---|---|
| NefopamPatients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1. | Drug | nefopam and propacetamol group, nefopam group |
| PropacetamolPatients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1. | Drug | nefopam and propacetamol group, propacetamol group |
Primary outcome
VAS score on wound site and posterior neck
Time frame: one hour after the surgery
Patients' subject pain score through VAS on the surgery wound site and posterior neck.
5 secondary outcomes
Additional pain rescue drug
Time frame: for postop. 24hrs.
Postoperative nausea and vomiting
Time frame: for postop. 24hrs.
Patient satisfaction
Time frame: for postop. 24hrs.
Chronic pain and neurogenic pain
Time frame: three month after the surgery.
acute VAS on wound site and posterior neck
Time frame: postop. 24hrs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: PubMed 16839262Han DW, Koo BN, Chung WY, Park CS, Kim SY, Palmer PP, Kim KJ. Preoperative greater occipital nerve block in total thyroidectomy patients can reduce postoperative occipital headache and posterior neck pain. Thyroid. 2006 Jun;16(6):599-603. doi: 10.1089/thy.2006.16.599.
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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 study testing Nefopam and Propacetamol in people with Thyroidectomy and Pain, run by Yonsei University 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 21 Mar 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS score on wound site and posterior neck (time frame: one hour after the surgery). 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 NCT02577068, 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 21 Mar 2019.