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

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05037994

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Shoulder	Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 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
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 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

Arm

Intervention/Treatment

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

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

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

Other Names:

Oral gabapentin 300 mg at bed time in GG

Outcome Measures

Primary Outcome Measures

Visual analogue scale [6 weeks]
10cm line where zero means no pain and ten means worse imaginary pain

Secondary Outcome Measures

Range of passive and active movements [6 weeks]
by goniometer
Patients satisfaction [6 weeks]
by questionnaire with 3 degrees Fair Good Excellent

Other Outcome Measures

The total dose of diclofenac sodium [6 weeks]
Indicator for analgesia required

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

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.