Back to results

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

Primary Purpose

Pain, Shoulder

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

About this trial

This is an interventional supportive care trial for Pain, Shoulder

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Amr Shaaban Elshafei

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group (C Group)

Gabapentin Group (G Group)

Arm Description

Patients will receive continuous US suprascapular nerve block only.

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

Outcomes

Primary Outcome Measures

Visual analogue scale

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

Secondary Outcome Measures

Range of passive and active movements

by goniometer

Patients satisfaction

by questionnaire with 3 degrees Fair Good Excellent

Full Information

NCT ID

NCT05037994

First Posted

September 3, 2021

Last Updated

November 14, 2021

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT05037994

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Shoulder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group (C Group)

Arm Type

Placebo Comparator

Arm Description

Patients will receive continuous US suprascapular nerve block only.

Arm Title

Gabapentin Group (G Group)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

Other Intervention Name(s)

Oral gabapentin 300 mg at bed time in GG

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual analogue scale

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Range of passive and active movements

Description

by goniometer

Time Frame

6 weeks

Title

Patients satisfaction

Description

by questionnaire with 3 degrees Fair Good Excellent

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

The total dose of diclofenac sodium

Description

Indicator for analgesia required

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AHMAD S HEGAB, MD

Organizational Affiliation

Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University

Official's Role

Study Director

Facility Information:

Facility Name

Amr Shaaban Elshafei

City

Zagazig

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs