NCT06974630

Brief Summary

This study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

May 8, 2025

Last Update Submit

December 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4.

    48 hours postoperatively

Secondary Outcomes (4)

  • Time to the 1st rescue analgesia

    48 hours postoperatively

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Degree of pain

    48 hours postoperatively

  • Incidence of adverse events

    48 hours postoperatively

Study Arms (2)

ESPB group

EXPERIMENTAL

Patients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side.

Other: Cervical erector spinae plane block

SCPB group

ACTIVE COMPARATOR

Patients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck.

Other: Cervical plexus block

Interventions

Patients will receive bilateral ultrasound-guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% on each side.

Also known as: Bupivacaine 0.25%
ESPB group

Patients will receive bilateral ultrasound-guided superficial cervical block using 15 mL of 0.25% plain bupivacaine on each side of the neck.

Also known as: Bupivacaine 0.25%
SCPB group

Eligibility Criteria

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

You may qualify if:

  • Age from 18 to 65 years.
  • Both genders.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for either hemi- or total thyroidectomy.

You may not qualify if:

  • Known allergy to local anesthetics.
  • Allergy to all opioid medications.
  • Pregnant patient.
  • Previous neck surgery.
  • Recent use of non-steroidal anti-inflammatory drugs (NSAIDs), opioids or steroid injection within 2 weeks.
  • Those who cannot utilize the numeric rating scale (NRS) .
  • Chronic opioid use.
  • Coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

May 15, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations