Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery
- Conditions
- Postoperative PainThyroid DiseasesAnesthesia, Local
- Registration Number
- NCT04427904
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Inpatient analgesia utilization Up to 72 hours after surgery Quantity of standardized analgesia used during admission
Outpatient analgesia utilization Up to 4 weeks after surgery Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
Time to return of sensation Up to 4 weeks after surgery Patient reported time to return of sensation at surgical site
Incidence of postoperative complications 4 weeks Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
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.
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
Trial Locations
- Locations (1)
St. Joeseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada