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

NCT ID: NCT04993521

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized Controlled Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bilateral superficial cervical plexus block (BSCPB)

Analgesia obtained by a ultrasound guided cervical plexus block using lidocain

Group Type ACTIVE_COMPARATOR

Block type

Intervention Type PROCEDURE

Regular block type

local wound infiltration (LWI)

Analgesia obtained by local wound infiltration of lidocain

Group Type ACTIVE_COMPARATOR

Block type

Intervention Type PROCEDURE

Regular block type

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Block type

Regular block type

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ultrasound guided bilateral superficial cervical plexus nerve block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ahmed Mohamed Abdelrahman

UNKNOWN

Sponsor Role collaborator

Mahmoud Ahmed Mewafy

UNKNOWN

Sponsor Role collaborator

Abdelrhman Alshawadfy

UNKNOWN

Sponsor Role collaborator

Haidi Abd-Elzaher

UNKNOWN

Sponsor Role collaborator

Hamada Fathy

UNKNOWN

Sponsor Role collaborator

Mohamed Faisal

UNKNOWN

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Folke Sjoberg

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Linköping University Hospital

Linköping, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSCPB_Block

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.