Phase 3
Completed N=148
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Thyroid Neoplasm · Goiter
Source: ClinicalTrials.gov NCT02112370 ↗
Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: NRS Pain Scores for the First 12 Hours — 4.93; 4.12; 4.50; 3.69 points — p=0.008
◆ Published Evidence
Emerging
15citations · ~2 / year
Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).
Summary
To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in BABA endoscopic and robotic thyroidectomy.
Linked Publications
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Preoperative flap-site injection with ropivacaine and epinephrine in BABA robotic and endoscopic thyroidectomy safely reduces postoperative pain: A CONSORT-compliant double-blinded randomized controlled study (PAIN-BREKOR trial).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS Pain Scores for the First 12 Hours |
4.93; 4.12; 4.50; 3.69; 3.99; 3.16 | 0.008 sig |
| SECONDARY Maximum of Measured Systolic Blood Pressures |
142; 145 | — |
| SECONDARY Maximum of Measured Diastolic Blood Pressures |
91; 86 | — |
| SECONDARY Maximum of Measured Heart Rates |
88; 99 | — |
| SECONDARY Blood Loss Amount |
30; 18 | — |
| SECONDARY Operation Time |
163.6; 155.3 | — |
| SECONDARY NRS Change |
5.73; 5.68; 5.05; 4.7; 4.55; 4.11 | — |
| SECONDARY Pain Killer Dose |
1; 0.84; 0.35; 0.31; 0.31; 0.26 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of thyroid neoplasm or benign goiter
- Scheduled for BABA endoscopic or robotic thyroidectomy
Exclusion Criteria
- Completion thyroidectomy
- Modified radical neck dissection
- Allergy history
- Stroke history
- Uncontrolled hypertension
- Uncontrolled diabetes
- Coagulopathy
- Severe cardiovascular disease
- Severe pulmonary disease
- Chronic kidney disease
- Pregnant
Data sourced from ClinicalTrials.gov (NCT02112370) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.