Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial

Phase 2

Completed

• Conditions: Thyroidectomy
• Interventions: Drug: placebo bilateral superficial cervical block; Drug: bilateral superficial cervical block

• Registration Number: NCT00472446
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2015-11-24
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Results First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo cervical block after surgery	placebo bilateral superficial cervical block	placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
cervical block after surgery	bilateral superficial cervical block	bilateral superficial cervical block, placed after surgery (just after skin closure)
cervical block before surgery	bilateral superficial cervical block	bilateral superficial cervical block, placed before surgery (just before skin incision)
placebo cervical block before surgery	placebo bilateral superficial cervical block	placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Measured by Visual Analogue Scale	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	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 Outcome Measures

Name	Time	Method
Consumption of Post-operative Analgetics	5 days after surgery	number of participants taking post-operative analgetics
Mean Consumption of Post-operative Analgetics	5 days after surgery	mean pooled dose of post-operative analgetics
Post-operative Pain Measured by Visual Analogue Scale	24 hours after surgery	Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Hospital Stay	90 days	time from surgery to Hospital release in days

Trial Locations

Locations (1)

Department of Surgery, Cantonal Hospital of St. Gallen; 🇨🇭 St. Gallen, Switzerland