NCT05686395

Brief Summary

This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.

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 Jan 2023

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

First Submitted

Initial submission to the registry

January 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

January 6, 2023

Last Update Submit

December 16, 2024

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • post operative analgesic consumption

    The first 24 hours post operative analgesic consumption

    24 hours after surgery

Secondary Outcomes (3)

  • Visual Analogue score (VAS) in the first 24 hours after surgery

    first 24 hours after surgery

  • Patient satisfaction score

    first 24 hours after surgery

  • The incidence of hemi diaphragmatic paralysis

    immediately before block and immediately after procedure

Study Arms (2)

group 1 Ultrasound-guided Interscalene Block group

ACTIVE COMPARATOR

In this group, ultrasound-guided ISB will be done using 10 ml of bupivacaine 0.25%.

Procedure: Ultrasound-guided Interscalene Block groupDrug: Bupivacaine

group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

ACTIVE COMPARATOR

, ultrasound-guided SHAC block will be done using 10 ml of bupivacaine 0.25% injected in the interfacial plane between deltoid and subscapular muscle and 10 ml of bupivacaine 0.25% injected in the pericapsular space. Ultrasound-guided SSN block will be done using 10 ml of bupivacaine 0.25% injected at sub omohyoid space.

Procedure: Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve blockDrug: Bupivacaine

Interventions

Ultrasound-guided Interscalene Block groupPROCEDURE

ultrasound guided interscalene block versus combined ultrasound guided shoulder anterior capsular block and suprascapular nerve block for arthroscopic shoulder surgery

group 1 Ultrasound-guided Interscalene Block group
Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve blockPROCEDURE

Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

group 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block
BupivacaineDRUG

bupivacaine 0.25%.

group 1 Ultrasound-guided Interscalene Block groupgroup 2 Combined Ultrasound guided shoulder anterior capsular block and suprascapular nerve block

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.

You may not qualify if:

  • Patient refusal.
  • Uncooperative patient.
  • Patient with neurological deficit.
  • Patients with respiratory disorders.
  • Patient with bleeding disorders.
  • Infection at the block injection site.
  • Patients with history of allergy to local anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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 ANESTHESIA AND INTENSIVE CARE AND PAIN MEDICINE

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 17, 2023

Study Start

January 23, 2023

Primary Completion

August 11, 2024

Study Completion

August 11, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)