Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

• Sponsor: St. Joseph's Healthcare Hamilton (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04427904
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 5.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Thyroid Diseases; Anesthesia, Local	Drug: Bupivacaine 0.5% with 1:200 000 epinephrine; Drug: Lidocaine 2% with 1:100 000 epinephrine	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine 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; Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.; Other Names: Marcaine
Active Comparator: Lidocaine Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.	Drug: Lidocaine 2% with 1:100 000 epinephrine; Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.; Other Names: Xylocaine

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain [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

2. Postoperative Pain [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

3. Postoperative Pain [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

4. Postoperative Pain [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

5. Postoperative Pain [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

6. Postoperative Pain [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

7. Postoperative Pain [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

Secondary Outcome Measures

1. First dose of additional postoperative analgesia [Up to 72 hours after surgery]

   Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered

2. Inpatient analgesia utilization [Up to 72 hours after surgery]

   Quantity of standardized analgesia used during admission

3. Outpatient analgesia utilization [Up to 4 weeks after surgery]

   Quantity of standardized analgesia used between discharge and 4 week outpatient follow up

4. Time to return of sensation [Up to 4 weeks after surgery]

   Patient reported time to return of sensation at surgical site

5. Incidence of postoperative complications [4 weeks]

   Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia

6. Incidence of local anesthesia related adverse events [4 weeks]

   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.

7. Postoperative pain [1 week]

   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. Postoperative pain [2 week]

   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. Postoperative pain [4 week]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joeseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N4A6

Sponsors and Collaborators

• St. Joseph's Healthcare Hamilton

Investigators

• Principal Investigator: Han Zhang, MD FRCSC, St. Joseph's Hospital Hamilton

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Xie, Resident Physician, St. Joseph's Healthcare Hamilton
• ClinicalTrials.gov Identifier: NCT04427904
• Other Study ID Numbers: 7336
• First Posted: Jun 11, 2020
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Xie, Resident Physician, St. Joseph's Healthcare Hamilton: Thyroidectomy; Bupivacaine; Lidocaine
• Additional relevant MeSH terms: Thyroid Diseases; Pain, Postoperative; Lidocaine; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate

Study Results

No Results Posted as of Oct 12, 2021