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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Analgesia Obtained With a Local Wound Infiltration of Lidocain; Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain
• Intervention / Treatment: Procedure: Block type

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Linkoping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Ahmed Mohamed Abdelrahman; Mahmoud Ahmed Mewafy; Abdelrhman Alshawadfy; Haidi Abd-Elzaher; Hamada Fathy; Mohamed Faisal

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Agnosia
• Other Study ID Numbers: BSCPB_Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Can be shared on reasonable terms

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No