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

NCT05037994 | Completed

• 1 other identifier: 6909
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Shoulder

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

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

  6 weeks

Secondary Outcomes (2)

• Range of passive and active movements

  6 weeks

• Patients satisfaction

  6 weeks

Other Outcomes (1)

• The total dose of diclofenac sodium

  6 weeks

Study Arms (2)

Control Group (C Group)

PLACEBO COMPARATOR

Patients will receive continuous US suprascapular nerve block only.

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

Gabapentin Group (G Group)

EXPERIMENTAL

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

Interventions

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.

Also known as: Oral gabapentin 300 mg at bed time in GG

Control Group (C Group); Gabapentin Group (G Group)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Amr Shaaban Elshafei

Zagazig, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Bupivacaine; Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• AHMAD S HEGAB, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AMR SHAABAN ELSHAFEI

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 8, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 30, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)