Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.

Study Overview
=================
Brief Summary
-----------------
The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy

Detailed Description
-----------------
We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment. Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline. The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.

Official Title
-----------------
Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study

Conditions
-----------------
Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Block type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II, and were scheduled for total thyroidectomy - Exclusion Criteria: documented allergy to study's intervention, moderate-to-severe obesity, > 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill the informed consent before enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized Controlled Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bilateral superficial cervical plexus block (BSCPB)<br>Analgesia obtained by a ultrasound guided cervical plexus block using lidocain | Procedure: Block type<br>* Regular block type<br>* Other names: Ultrasound guided bilateral superficial cervical plexus nerve block;|
| Active Comparator: local wound infiltration (LWI)<br>Analgesia obtained by local wound infiltration of lidocain | Procedure: Block type<br>* Regular block type<br>* Other names: Ultrasound guided bilateral superficial cervical plexus nerve block;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative opioid consumption in the first postoperative day | postoperative opioid consumption in the first postoperative day in milligrams | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total intraoperative fentanyl (mg) and isoflurane consumption (ml) | total intraoperative fentanyl and isoflurane consumption in micrograms and ml | 6 hours | 
| time to first required analgesic | time to first required analgesic | 6 hours | 
| VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively | VAS (10 cm; range) Pain average (VAS) for the first 24 hours postoperatively | every 6 hours until 24 hours postoperatively |