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

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

Study Overview

• Status: Completed
• Conditions: Pain, Shoulder
• Intervention / Treatment: Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Amr Shaaban Elshafei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	10cm line where zero means no pain and ten means worse imaginary pain	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of passive and active movements	by goniometer	6 weeks
Patients satisfaction	by questionnaire with 3 degrees; Fair; Good; Excellent	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of diclofenac sodium	Indicator for analgesia required	6 weeks

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: AHMAD S HEGAB, MD, Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): October 30, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (ACTUAL): September 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Antimanic Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Gabapentin; Bupivacaine
• Other Study ID Numbers: 6909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No