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OpenTrials
Completed

NCT Number: NCT05037994

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

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

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Key information

Conditions

Pain, Shoulder Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amr Shaaban Elshafei

Zagazig, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

Procedure

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.

Other names: Oral gabapentin 300 mg at bed time in GG

Primary outcomes

  1. Visual analogue scale

    Time frame: 6 weeks

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

Secondary outcomes

  1. Range of passive and active movements

    Time frame: 6 weeks

    by goniometer

  2. Patients satisfaction

    Time frame: 6 weeks

    by questionnaire with 3 degrees

    • Fair
    • Good
    • Excellent

Other outcomes

  1. The total dose of diclofenac sodium

    Time frame: 6 weeks

    Indicator for analgesia required

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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