NCT06913140

Brief Summary

This study was conducted to compare the perioperative analgesic effect of ultrasound guided high thoracic erector spinae plane block versus ultrasound guided costoclavicular block for shoulder arthroscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

March 29, 2025

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Pethidine consumption

    Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable") at (T 30 min, 2, 4, 6,12, 18, 24 h, non-steroidal anti-inflammatory drugs were given (ketorolac 30mg) to all patient /8 h and if VAS \> 4 intravenous pethidine 0.5 mg / kg per dose.

    24 hours postoperatively

Secondary Outcomes (3)

  • Time to first analgesic request after surgery

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Complications

    24 hours postoperatively

Study Arms (3)

Erector Spinae plane Block group

EXPERIMENTAL

Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2)

Drug: Erector Spinae plane Block

Costoclavicular block group

EXPERIMENTAL

Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery

Drug: Costoclavicular block

Control group

SHAM COMPARATOR

Patients received sham block .

Drug: Control group

Interventions

Patients received (20ml) plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath at the level of the second thoracic segment (T2)

Also known as: Bupivacaine 0.25%
Erector Spinae plane Block group

Patients received (20ml) plain bupivacaine 0.25% injected in the costoclavicular space lateral to axillary artery.

Also known as: Bupivacaine 0.25%
Costoclavicular block group

Patients received sham block

Also known as: Sham block
Control group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted for elective unilateral shoulder arthroscopy.
  • Aged (21 - 65) years.
  • American Society of Anesthesiologists (ASA) physical activity I, II

You may not qualify if:

  • Patient refusal.
  • Patient with neurological deficit.
  • Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant and antiplatelets drugs).
  • Uncooperative patient.
  • Infection at the block injection site.
  • Patients with history of allergy to local anaesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

December 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

April 25, 2025

Record last verified: 2025-04

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