NCT07496970

Brief Summary

Patients undergoing thyroidectomy frequently experience moderate postoperative pain that may require opioid analgesics. Opioid use is associated with adverse effects such as nausea, vomiting, respiratory depression, and delayed recovery. Ultrasound-guided regional anesthesia techniques may provide effective postoperative analgesia while reducing opioid consumption. The aim of this prospective randomized study was to evaluate the analgesic efficacy of ultrasound-guided bilateral superficial cervical plexus block (BSCPB) in patients undergoing thyroidectomy under general anesthesia. Patients were divided into two groups: a block group receiving BSCPB with 0.5% bupivacaine and a control group receiving general anesthesia alone. Postoperative pain scores, opioid consumption, intraoperative analgesic requirements, and postoperative complications were compared between the groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 13, 2026

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain intensity (VAS)

    Postoperative pain assessed using the Visual Analog Scale (0-100 mm)

    Within the first 24 hours after surgery

  • Postoperative pain intensity (NRS)

    Description: Postoperative pain assessed using the Numeric Rating Scale (0-10)

    Within the first 24 hours after surgery

Study Arms (2)

Bilateral Superficial Cervical Plexus Block

EXPERIMENTAL

Patients received ultrasound-guided bilateral superficial cervical plexus block using 10 ml of 0.5% bupivacaine on each side (total 20 ml) along the posterior border of the sternocleidomastoid muscle using the three-injection technique prior to thyroidectomy. The procedure was performed under ultrasound guidance in addition to standard general anesthesia.

Procedure: Ultrasound-Guided Bilateral Superficial Cervical Plexus BlockProcedure: Standard general anesthesia

General Anesthesia Only

ACTIVE COMPARATOR

Patients underwent thyroidectomy under standard general anesthesia without cervical plexus block. Perioperative anesthesia management was performed according to routine institutional practice.

Procedure: Standard general anesthesia

Interventions

Intervention Description: Patients received an ultrasound-guided bilateral superficial cervical plexus block prior to surgery. A total of 20 ml of 0.5% bupivacaine (10 ml per side) was injected along the posterior border of the sternocleidomastoid muscle using the three-injection technique. The block was performed under ultrasound guidance before induction of general anesthesia to provide perioperative analgesia.

Bilateral Superficial Cervical Plexus Block

only general anesthesia

Bilateral Superficial Cervical Plexus BlockGeneral Anesthesia Only

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective surgery under general anesthesia Ability to provide written informed consent

You may not qualify if:

  • Allergy to local anesthetic agents Coagulation disorders or anticoagulant use Infection at the injection site Severe cardiac, respiratory, hepatic, or renal disease Pregnancy or breastfeeding Inability to understand pain scoring systems (VAS/NRS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Elzem Sen, Assoc Prof

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.Dr

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 27, 2026

Study Start

March 15, 2023

Primary Completion

June 30, 2023

Study Completion

July 15, 2023

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations