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Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

Primary Purpose

Postoperative Pain, Thyroid Diseases, Anesthesia, Local

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bupivacaine 0.5% with 1:200 000 epinephrine
Lidocaine 2% with 1:100 000 epinephrine
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Thyroidectomy, Bupivacaine, Lidocaine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joeseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bupivacaine

Lidocaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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

Secondary Outcome Measures

First dose of additional postoperative analgesia
Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered
Inpatient analgesia utilization
Quantity of standardized analgesia used during admission
Outpatient analgesia utilization
Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
Time to return of sensation
Patient reported time to return of sensation at surgical site
Incidence of postoperative complications
Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
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.
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
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
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

Full Information

First Posted
May 26, 2020
Last Updated
October 29, 2022
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04427904
Brief Title
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery
Official Title
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Thyroid Diseases, Anesthesia, Local
Keywords
Thyroidectomy, Bupivacaine, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% with 1:200 000 epinephrine
Other Intervention Name(s)
Marcaine
Intervention Description
Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% with 1:100 000 epinephrine
Other Intervention Name(s)
Xylocaine
Intervention Description
Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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
Time Frame
30 minutes after surgery
Title
Postoperative Pain
Description
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
Time Frame
1 hour after surgery
Title
Postoperative Pain
Description
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
Time Frame
2 hours after surgery
Title
Postoperative Pain
Description
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
Time Frame
3 hours after surgery
Title
Postoperative Pain
Description
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
Time Frame
4 hours after surgery
Title
Postoperative Pain
Description
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
Time Frame
8 hours after surgery
Title
Postoperative Pain
Description
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
Time Frame
12 hours after surgery
Secondary Outcome Measure Information:
Title
First dose of additional postoperative analgesia
Description
Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered
Time Frame
Up to 72 hours after surgery
Title
Inpatient analgesia utilization
Description
Quantity of standardized analgesia used during admission
Time Frame
Up to 72 hours after surgery
Title
Outpatient analgesia utilization
Description
Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
Time Frame
Up to 4 weeks after surgery
Title
Time to return of sensation
Description
Patient reported time to return of sensation at surgical site
Time Frame
Up to 4 weeks after surgery
Title
Incidence of postoperative complications
Description
Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
Time Frame
4 weeks
Title
Incidence of local anesthesia related adverse events
Description
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.
Time Frame
4 weeks
Title
Postoperative pain
Description
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
Time Frame
1 week
Title
Postoperative pain
Description
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
Time Frame
2 week
Title
Postoperative pain
Description
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
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Xie, MD
Phone
(905) 522-1155
Ext
4765
Email
michael.xie@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Han Zhang, MD FRCSC
Phone
(905) 521-2100
Ext
37031
Email
hanzhang@stjosham.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Zhang, MD FRCSC
Organizational Affiliation
St. Joseph's Hospital Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joeseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Xie, MD
Phone
(905) 522-1155
Ext
4765
Email
michael.xie@medportal.ca
First Name & Middle Initial & Last Name & Degree
Han Zhang, MD FRCSC
Phone
(905) 521-2100
Ext
37031
Email
hanzhang@stjosham.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

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