Postoperative PainPhase 2NCT04427904
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery
A Phase 2 study testing Bupivacaine 0.5% with 1:200 000 epinephrine and Lidocaine 2% with 1:100 000 epinephrine in people with Postoperative Pain and Thyroid Diseases, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Pain, Thyroid Diseases, Anesthesia, Local
- What is being tested?
- Bupivacaine 0.5% with 1:200 000 epinephrine and Lidocaine 2% with 1:100 000 epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 31 Dec 2025
- Phase
- Phase 2
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)
- Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)
- Will be admitted for at least 12h postoperatively
Who cannot join
- Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy
- Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)
- Previous ipsilateral thyroid surgery to operation side
- Previous total thyroidectomy or completion thyroidectomy
- History of neck radiation therapy
- Neck dissection beyond central neck (levels 1-5)
Show all 14Show fewer
- Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy
- Surgery requiring extension of incision beyond 8 cm
- History of diabetes mellitus
- History of renal or liver disease
- History of narcotic abuse
- History of chronic pain medications use in past 6 months for any condition
- History of coagulation defect
- Allergy to Bupivacaine or Lidocaine
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joeseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
Michael Xie, MD, (905) 522-1155 ext. 4765, michael.xie@medportal.ca
Han Zhang, MD FRCSC, (905) 521-2100 ext. 37031, hanzhang@stjosham.on.ca
About this study
Official title: Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.
Read the detailed description
Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).
- Conditions
- Postoperative Pain, Thyroid Diseases, Anesthesia, Local
- Being tested
- Bupivacaine 0.5% with 1:200 000 epinephrine, Lidocaine 2% with 1:100 000 epinephrine
- Keywords
- Thyroidectomy, Bupivacaine, Lidocaine
- Medical subject headings
- Pain, Postoperative, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% with 1:200 000 epinephrineDrug
Also called Marcaine
Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Lidocaine 2% with 1:100 000 epinephrineDrug
Also called Xylocaine
Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. Receives: Drug: Bupivacaine 0.5% with 1:200 000 epinephrine |
| Lidocaine | Active comparator | Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. Receives: Drug: Lidocaine 2% with 1:100 000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 30 minutes after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 1 hour after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 2 hours after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 3 hours after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 4 hours after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 8 hours after surgery
Postoperative Pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 12 hours after surgery
Secondary outcomes (9)
First dose of additional postoperative analgesia
Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered
Measured: Up to 72 hours after surgery
Inpatient analgesia utilization
Quantity of standardized analgesia used during admission
Measured: Up to 72 hours after surgery
Outpatient analgesia utilization
Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
Measured: Up to 4 weeks after surgery
Time to return of sensation
Patient reported time to return of sensation at surgical site
Measured: Up to 4 weeks after surgery
Incidence of postoperative complications
Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
Measured: 4 weeks
Incidence of local anesthesia related adverse events
Incidence of adverse events including CNS (tinnitus, blurred vision, dizziness, tongue paresthesias, circumoral numbness, seizures, CNS depression) and cardiovascular (hear block, sinus bradycardia, sinus arrest, ventricular arrhythmias) events.
Measured: 4 weeks
Postoperative pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 1 week
Postoperative pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 2 week
Postoperative pain
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Xie, St. Joseph's Healthcare Hamilton
- Investigators
- Han Zhang, MD FRCSC, Principal investigator, St. Joseph's Hospital Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427904
- Sponsor's protocol ID
- 7336
- Status last verified
- Nov 2023
- First submitted
- 26 May 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04427904
- Acronym / sponsor ID
- 7336
- Conditions
- Postoperative Pain, Thyroid Diseases, Anesthesia, Local
- Keywords
- Thyroidectomy, Bupivacaine, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jun 2020 (actual)
- 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.
The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.
Detailed description
Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaine 0.5% with 1:200 000 epinephrineBupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
| Lidocaine | Active comparator | Drug: Lidocaine 2% with 1:100 000 epinephrineLidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)
- Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)
- Will be admitted for at least 12h postoperatively
Key exclusion criteria (14 listed)
- Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy
- Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)
- Previous ipsilateral thyroid surgery to operation side
- Previous total thyroidectomy or completion thyroidectomy
- History of neck radiation therapy
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 |
|---|---|---|
| Bupivacaine 0.5% with 1:200 000 epinephrineAlso: MarcaineBupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision. | Drug | Bupivacaine |
| Lidocaine 2% with 1:100 000 epinephrineAlso: XylocaineLidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision. | Drug | Lidocaine |
Primary outcome
Postoperative Pain
Time frame: 30 minutes after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 1 hour after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 2 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 3 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 4 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 8 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
Postoperative Pain
Time frame: 12 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
9 secondary outcomes
First dose of additional postoperative analgesia
Time frame: Up to 72 hours after surgery
Inpatient analgesia utilization
Time frame: Up to 72 hours after surgery
Outpatient analgesia utilization
Time frame: Up to 4 weeks after surgery
Time to return of sensation
Time frame: Up to 4 weeks after surgery
Incidence of postoperative complications
Time frame: 4 weeks
Incidence of local anesthesia related adverse events
Time frame: 4 weeks
Postoperative pain
Time frame: 1 week
Postoperative pain
Time frame: 2 week
Postoperative pain
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Han Zhang, MD FRCSC principal investigator
St. Joseph's Hospital Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine 0.5% with 1:200 000 epinephrine and Lidocaine 2% with 1:100 000 epinephrine in people with Postoperative Pain and Thyroid Diseases, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 14 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Xie, MD ((905) 522-1155 ext. 4765, michael.xie@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 30 minutes after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.