NCT05978427

Brief Summary

Efficacy and safety of superior trunk block versus interscalene block for post-operative analgesia in shoulder surgeries

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 2023

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

Study Start

First participant enrolled

May 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 28, 2024

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

July 30, 2023

Last Update Submit

June 27, 2024

Conditions

Superior Trunk Block Versus Interscalene Block for Post-operative Analgesia in Shoulder Surgeries

Keywords

superior trunk blockinterscalene block

Outcome Measures

Primary Outcomes (1)

  • diaphragmatic paralysis postoperative

    o The incidence of diaphragmatic paralysis postoperative assessed by Diaphragmatic excursion distance by Ultrasound

    within 24 hours after surgery

Secondary Outcomes (3)

  • analgesic efficacy

    within 24 hours after surgery

  • rescue analgesia

    within 24 hours after surgery

  • Post operative nausea and vomiting

    within 24 hours after surgery

Study Arms (2)

interscalene block group

ACTIVE COMPARATOR

participants undergoing shoulder surgeries will receive ultrasound guided interscalene block

Procedure: interscalene blockProcedure: superior trunk block

superior trunk block group

ACTIVE COMPARATOR

participants undergoing shoulder surgeries will receive ultrasound guided superior trunk block

Procedure: interscalene blockProcedure: superior trunk block

Interventions

interscalene blockPROCEDURE

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in interscalene block.

interscalene block groupsuperior trunk block group
superior trunk blockPROCEDURE

will receive a 20 ml mixture of local anesthetic solution prepared as 10 ml of bupivacaine 0.5% diluted with 10 ml normal saline 0.9% will be injected in superior trunk block.

interscalene block groupsuperior trunk block group

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients American Society of Anaesthesiologists physical status (ASA) is I to II.
  • Both genders.
  • Aged group from 21 to 50 years old.
  • Patients electively scheduled for shoulder surgery under general anesthesia with normal coagulation profile.

You may not qualify if:

  • Refusal of the procedure or participation in the study.
  • Any history or evidence of coagulopathy.
  • Evidence of infection at injection site.
  • Allergy to study drugs.
  • Patients with pulmonary severe respiratory disease.
  • Herniated cervical disc or cervical myelopathy.
  • Pre-existing neuropathy of the operative limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

June 28, 2024

Record last verified: 2023-05

Locations

EG(1)