NCT04427904

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Jun 2022

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

May 26, 2020

Last Update Submit

November 26, 2023

Conditions

Postoperative PainThyroid DiseasesAnesthesia, Local

Keywords

ThyroidectomyBupivacaineLidocaine

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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

    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

    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

    12 hours after surgery

Secondary Outcomes (9)

  • First dose of additional postoperative analgesia

    Up to 72 hours after surgery

  • Inpatient analgesia utilization

    Up to 72 hours after surgery

  • Outpatient analgesia utilization

    Up to 4 weeks after surgery

  • Time to return of sensation

    Up to 4 weeks after surgery

  • Incidence of postoperative complications

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Bupivacaine

EXPERIMENTAL

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

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.

Drug: Lidocaine 2% with 1:100 000 epinephrine

Interventions

Bupivacaine 0.5% with 1:200 000 epinephrineDRUG

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

Also known as: Marcaine
Bupivacaine
Lidocaine 2% with 1:100 000 epinephrineDRUG

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

Also known as: Xylocaine
Lidocaine

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joeseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeThyroid Diseases

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • Han Zhang, MD FRCSC

    St. Joseph's Hospital Hamilton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Xie, MD

CONTACT

(905) 522-1155michael.xie@medportal.ca

Han Zhang, MD FRCSC

CONTACT

(905) 521-2100hanzhang@stjosham.on.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 11, 2020

Study Start

June 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)