NCT04709250

Brief Summary

Patients undergoing total shoulder arthroscopic adhesiolysis may experience severe postoperative pain. Inadequate pain management can result in unfavourable hospital outcomes and the development of persistent neuropathic manifestation the aim of the study is to compare both ultrasound techniques (combined individual nerve block to interscalene nerve block) as regards the postoperative analgesic effect and shoulder range of movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

January 7, 2021

Last Update Submit

February 11, 2022

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • the duration of postoperative analgesia

    postoperative pain by visual analogue scale (VAS) a 10 point scale where 1 means no pain and 10 means worst pain ever

    24 hours postoperative

Secondary Outcomes (1)

  • range of motion of the operated shoulder

    24 hours postoperative

Study Arms (2)

group A: receive ultrasound-guided interscalene block

ACTIVE COMPARATOR

The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine consistent with the overall local anaesthetic dosing of less than 2.5 mg/kg. will be injected with low pressures to avoid intraneural injection.

Procedure: interscalene blockDrug: bupivacaine

group B: receive ultrasound-guided selective nerve block

ACTIVE COMPARATOR

The patient will be put in the sitting position, a linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to obtain a view of the suprascapular nerve a 22 G, 8 cm needle will be advanced in-plane and a total of 5-8 mL of 0.25% bupivacaine is injected then the arm adducted the linear probe will be placed at the junction of the pectoralis major muscle and the biceps muscle such that the axillary artery will be visualized in cross-section The probe will be moved towards the biceps muscle (laterally) until the musculocutaneous nerve is visualized and8 ml of 0.25% bupivacaine will be injected

Procedure: selective nerve blockDrug: bupivacaine

Interventions

interscalene blockPROCEDURE

The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine will be injected

group A: receive ultrasound-guided interscalene block
selective nerve blockPROCEDURE

the patient will be put in the sitting position, linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to view of the suprascapular nerve. 5-8 mL of 0.25% bupivacaine is injected to block the SSN. The ultrasound probe put on the posterior aspect of the shoulder to view the circumflex artery, 10 mL of 0.25% bupivacaine this will lead to loss of sensation over the deltoid.lateral pectoral nerve block (LPNB) will be done by injecting a volume of 8 ml of a 0.25% bupivacaine The probe will be moved towards the biceps muscle until the musculocutaneous nerve is seen and 8 ml of 0.25% bupivacaine will be injected.

group B: receive ultrasound-guided selective nerve block
bupivacaineDRUG

bupivacaine

group A: receive ultrasound-guided interscalene blockgroup B: receive ultrasound-guided selective nerve block

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I, II
  • scheduled for arthroscopic assisted adhesiolysis

You may not qualify if:

  • restrictive lung disease,
  • refusal of the procedure,
  • coagulopathy,
  • allergy to any of the used medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 69711, 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 Officials

  • Fathy M Tash, MD

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anaesthesia

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 14, 2021

Study Start

January 1, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

EG(1)