Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

Postoperative Pain Clinical Trial

Official title:

Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427904
• Other study ID #: 7336
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Michael Xie, MD
• Phone: (905) 522-1155
• Email: michael.xie[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative
• Postoperative Pain
• Thyroid Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	St. Joeseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	First dose of additional postoperative analgesia	Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered	Up to 72 hours after surgery
Secondary	Inpatient analgesia utilization	Quantity of standardized analgesia used during admission	Up to 72 hours after surgery
Secondary	Outpatient analgesia utilization	Quantity of standardized analgesia used between discharge and 4 week outpatient follow up	Up to 4 weeks after surgery
Secondary	Time to return of sensation	Patient reported time to return of sensation at surgical site	Up to 4 weeks after surgery
Secondary	Incidence of postoperative complications	Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia	4 weeks
Secondary	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.	4 weeks
Secondary	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 week
Secondary	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 week
Secondary	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 week