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Clinical Trials/NCT05037994
NCT05037994CompletedNot Applicable

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

Zagazig University1 site in 1 country40 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Visual analogue scale

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Control Group (C Group)

Placebo Comparator

Patients will receive continuous US suprascapular nerve block only.

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

Gabapentin Group (G Group)

Experimental

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

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

Outcomes

Primary Outcomes

Visual analogue scale

Time Frame: 6 weeks

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

Secondary Outcomes

  • Range of passive and active movements(6 weeks)
  • Patients satisfaction(6 weeks)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Amr Shaaban Elshafei

AMR SHAABAN ELSHAFEI

Zagazig University

Study Sites (1)

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