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CompletedNCT05037994Updated Nov 16, 2021

Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder

An interventional study of Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine in Pain, Shoulder, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Zagazig University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study summary

The patients will be randomly allocated into two equal groups (each 20 patients) using sealed opaque numbered envelopes:

Control Group (C Group) : Patients receive continuous US suprascapular nerve block only.

Gabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.

Both groups compared as regard:

Visual Analogue Scale Range of passive and active movements Patients satisfaction complication related to block The total dose of diclofenac sodium

02

Conditions studied

  • Pain, Shoulder
03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 371 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2
  • ASA I, II or III.
  • Cooperative patients.

Exclusion criteria

Exclusion Criteria:

  • local infection at site of injection.
  • coagulopathy
  • previous history of mental disorders or chronic drug abuse (opioids, tranquilizers)
  • known hypersensitivity to any of the drugs used in the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Control Group (C Group)

    Patients will receive continuous US suprascapular nerve block only.

    Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

  • Experimental
    Gabapentin Group (G Group)

    Patients will receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.

    Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

Interventions

  • ProcedureUltrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

    The high frequency linear ultrasound transducer (Sonosite 6-13 MHz) in a transverse orientation will be placed over the scapular Spine. Moving the transducer cephalad the suprascapular fossa will be identified. 18 gauge touhy needle will be inserted in plane after subcutaneous local anesthesia infiltration with 1 ml lidocaine 2% Real-time imaging will be used to direct injection of 2 ml lidocaine 2% to test perineural spread of injectate after confirmation of the position of tip of needle injection of 40mg methyl prednisolone diluted in 5 ml bupivacaine 0.5% will be done through the needle to anesthetize the nerve and create space for catheter insertion. After catheter insertion another 2 ml lidocaine 2% will be injected through the catheter to confirm position perineural in the scapular notch. Lastly Catheter will be fixed via skin tunnel and secured with skin sutures and adhesive tap.

    Also known as: Oral gabapentin 300 mg at bed time in GG

06

What researchers measure

Primary outcomes

  1. Visual analogue scale

    10cm line where zero means no pain and ten means worse imaginary pain

    Time frame: 6 weeks

Secondary outcomes

  1. Range of passive and active movements

    by goniometer

    Time frame: 6 weeks

  2. Patients satisfaction

    by questionnaire with 3 degrees 1. Fair 2. Good 3. Excellent

    Time frame: 6 weeks

Other outcomes

  1. The total dose of diclofenac sodium

    Indicator for analgesia required

    Time frame: 6 weeks

07

Study locations

1 site
  • Amr Shaaban Elshafei
    Zagazig, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05037994
Lead sponsor
Zagazig University
Responsible party
Amr Shaaban Elshafei (AMR SHAABAN ELSHAFEI, Zagazig University) — Principal investigator
First posted
Sep 8, 2021
Start date
Apr 1, 2021
Primary completion
Sep 1, 2021
Completion
Oct 30, 2021
Last update
Nov 16, 2021

Study contacts

AHMAD S HEGAB, MD
study director · Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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