CClinicalTrials.gg
Sign In
Status unknownNCT02397330Updated Mar 24, 2015

is There an Alternative to Ultrasound Guided Interscalene Block?

An interventional study of bupivacaine and ultrasound in Regional Anesthesia, Interscalene Block and Shoulder Surgery, sponsored by Tunisian Military Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Tunisian Military Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.

02

Conditions studied

  • Regional Anesthesia
  • Interscalene Block
  • Shoulder Surgery
03

In context

Lead sponsor

Tunisian Military Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA physical status I-III
  • 18-75 years of age, inclusive
  • shoulder surgery (LATARJET technique)

Exclusion criteria

Exclusion Criteria:

  • contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  • existing neurological deficit
  • pregnancy
  • history of neck surgery or radiotherapy
  • severe respiratory disease
  • inability to understand the informed consent and demands of the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group BIS

    scheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25%

    Drug: bupivacaine · Device: ultrasound · Drug: morphine

  • Experimental
    group BS

    scheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks

    Drug: bupivacaine · Device: ultrasound · Drug: morphine

Interventions

  • Drugbupivacaine
  • Deviceultrasound

    ultrasound guided nerve blocks

  • Drugmorphine
06

What researchers measure

Primary outcomes

  1. Visual Analogic Scale

    quality of postoperative analgesia

    Time frame: until 48 hours postoperative

Secondary outcomes

  1. time to perform the blocks

    Time frame: up to 5 minutes

  2. patient satisfaction

    scale from 0 (not satisfied at all) to 100 (full satisfaction)

    Time frame: 48 hours post performing nerves blocks

  3. occurrence of complications

    Time frame: 48 hours post performing nerves blocks

  4. total dose of morphine consumption in mg

    Time frame: during 48 hours post operative

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Trabelsi W, Ben Gabsia A, Lebbi A, Sammoud W, Labbene I, Ferjani M. Suprascapular block associated with supraclavicular block: An alternative to isolated interscalene block for analgesia in shoulder instability surgery? Orthop Traumatol Surg Res. 2017 Feb;103(1):77-83. doi: 10.1016/j.otsr.2016.10.012. Epub 2016 Dec 2. PubMed 27916737 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02397330
Lead sponsor
Tunisian Military Hospital
Responsible party
Dr trabelsi walid (associate professor, MD, Tunisian Military Hospital) — Principal investigator
First posted
Mar 24, 2015
Start date
Apr 2015
Primary completion
May 2015 (estimated)
Completion
May 2015 (estimated)
Last update
Mar 24, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Tunisian Military Hospital

Start the discussion