Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04427904
Other study ID # 7336
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A