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

Not Applicable

Completed

• Conditions: Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain; Postoperative Pain; Analgesia Obtained With a Local Wound Infiltration of Lidocain
• Interventions: Procedure: Block type

• Registration Number: NCT04993521
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-05-15
• Study First Submitted: 2021-06-10
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral superficial cervical plexus block (BSCPB)	Block type	Analgesia obtained by a ultrasound guided cervical plexus block using lidocain
local wound infiltration (LWI)	Block type	Analgesia obtained by local wound infiltration of lidocain

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption in the first postoperative day	24 hours	postoperative opioid consumption in the first postoperative day in milligrams

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Linköping University Hospital; 🇸🇪 Linköping, Sweden