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Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

NCT ID: NCT04427904

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.

Detailed Description

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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

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Postoperative Pain Thyroid Diseases Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupivacaine

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Group Type EXPERIMENTAL

Bupivacaine 0.5% with 1:200 000 epinephrine

Intervention Type DRUG

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Lidocaine

Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Group Type ACTIVE_COMPARATOR

Lidocaine 2% with 1:100 000 epinephrine

Intervention Type DRUG

Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Interventions

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Bupivacaine 0.5% with 1:200 000 epinephrine

Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Intervention Type DRUG

Lidocaine 2% with 1:100 000 epinephrine

Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.

Intervention Type DRUG

Other Intervention Names

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Marcaine Xylocaine

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Michael Xie

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han Zhang, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital Hamilton

Locations

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St. Joeseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Michael Xie, MD

Role: CONTACT

[email protected]
(905) 522-1155 ext. 4765

Han Zhang, MD FRCSC

Role: CONTACT

[email protected]
(905) 521-2100 ext. 37031

Facility Contacts

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Michael Xie, MD

Role: primary

[email protected]
(905) 522-1155 ext. 4765

Han Zhang, MD FRCSC

Role: backup

[email protected]
(905) 521-2100 ext. 37031

Other Identifiers

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7336

Identifier Type: -

Identifier Source: org_study_id