NCT06519851

Brief Summary

The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

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

July 6, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

July 6, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.

    Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain)

    Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.

Secondary Outcomes (2)

  • The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively

    24 hours postoperatively

  • Any Complications related to the blocks

    24 hours postoperatively

Study Arms (2)

• SSNB & SHAC

ACTIVE COMPARATOR

patients will receive general anesthesia + ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space)

Other: suprascapular nerve block with 10 ml bupivacaine 0.25% & shoulder anterior capsule block with 30 ml bupivacaine 0.25%

• Interscalene

PLACEBO COMPARATOR

patients will receive general anesthesia + ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus.

Other: Interscalene block with 20 ml bupivacaine 0.25%

Interventions

postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) following shoulder surgery by ultrasound guided suprascapular nerve block (SSNB) with 10 ml bupivacaine 0.25% deep to the transverse scapular ligament and Shoulder anterior capsule (SHAC) block with 30 ml bupivacaine 0.25% (20 ml deep to the deltoid muscle between the deltoid and subscapularis tendon \&10mL in the pericapsular space)

• SSNB & SHAC

postoperative analgesic effect of Interscalene block (ISB) following shoulder surgery by ultrasound guided interscalene brachial plexus block (ISB) with 20 ml bupivacaine 0.25% around C5-C6-C7 nerve roots of the brachial plexus

• Interscalene

Eligibility Criteria

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

You may qualify if:

  • Patients of both genders
  • patients aged 18-65 years
  • BMI of less than 30
  • American Society of Anesthesiologists (ASA) physical status I-II,
  • Patients scheduled for unilateral shoulder surgery under general anesthesia.

You may not qualify if:

  • Patient refusal
  • BMI of 30 or more
  • ASA III or more
  • Pregnancy or breast feeding
  • Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
  • Shoulder revision surgery
  • Pre-existing neurological deficits or neuropathy
  • Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, coagulopathy
  • Patients with chest problems not eligible for ISB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Pain

Interventions

BupivacaineDental Occlusion

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

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
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

July 6, 2024

First Posted

July 25, 2024

Study Start

August 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08