Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Post-operative Pain Measured by Visual Analogue Scale
Study Overview
Brief Summary
The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).
The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
- •Informed consent
Exclusion Criteria
- •Intolerance to used medication
- •Recurrent disease
- •Neck dissection, sternotomy
- •Emergency surgery
Arms & Interventions
cervical block before surgery
bilateral superficial cervical block, placed before surgery (just before skin incision)
Intervention: bilateral superficial cervical block (Drug)
placebo cervical block before surgery
placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)
Intervention: placebo bilateral superficial cervical block (Drug)
cervical block after surgery
bilateral superficial cervical block, placed after surgery (just after skin closure)
Intervention: bilateral superficial cervical block (Drug)
placebo cervical block after surgery
placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
Intervention: placebo bilateral superficial cervical block (Drug)
Outcomes
Primary Outcomes
Post-operative Pain Measured by Visual Analogue Scale
Time Frame: 6 hours after surgery
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Pooled Relative Treatment Effect of VAS
Time Frame: 4 days after surgery
Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain) The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)
Secondary Outcomes
- Hospital Stay(90 days)
- Consumption of Post-operative Analgetics(5 days after surgery)
- Mean Consumption of Post-operative Analgetics(5 days after surgery)
- Post-operative Pain Measured by Visual Analogue Scale(24 hours after surgery)
Investigators
Thomas Steffen
attending surgeon
Cantonal Hospital of St. Gallen