Ultrasound Guided Bilateral Superficial Cervical Plexus B... | NCT04993521

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Jan 31, 2021Actual

Completion Date

May 15, 2021Actual

First Submitted Date

Jun 10, 2021

First Submission Date that Met QC Criteria

Jul 28, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Aug 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Folke Sjoberg, professor, University Hospital, LinkoepingPrincipal Investigator

Lead Sponsor

University Hospital, LinkoepingOTHER

Collaborators

Name	Class
Ahmed Mohamed Abdelrahman	UNKNOWN
Mahmoud Ahmed Mewafy	UNKNOWN
Abdelrhman Alshawadfy	UNKNOWN
Haidi Abd-Elzaher

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bilateral superficial cervical plexus block (BSCPB)	Active Comparator	Analgesia obtained by a ultrasound guided cervical plexus block using lidocain	Procedure: Block type
local wound infiltration (LWI)	Active Comparator	Analgesia obtained by local wound infiltration of lidocain	Procedure: Block type

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Block type	Procedure	Regular block type	bilateral superficial cervical plexus block (BSCPB) local wound infiltration (LWI)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Linköping University Hospital		Linköping		58185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Can be shared on reasonable terms

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms