Pain, ShoulderNCT05037994
Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder
A study testing Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine in people with Pain, Shoulder, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Shoulder
- What is being tested?
- Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2
- ASA I, II or III.
- Cooperative patients.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pain, Shoulder
- Being tested
- Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaineProcedure or surgery
Also called Oral gabapentin 300 mg at bed time in GG
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (C Group) | Placebo comparator | Patients will receive continuous US suprascapular nerve block only. Receives: 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. Receives: Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
10cm line where zero means no pain and ten means worse imaginary pain
Measured: 6 weeks
Secondary outcomes (2)
Range of passive and active movements
by goniometer
Measured: 6 weeks
Patients satisfaction
by questionnaire with 3 degrees
- Fair
- Good
- Excellent
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ShoulderStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Elshafei, Zagazig University
- Investigators
- AHMAD S HEGAB, MD, Study director, Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037994
- Sponsor's protocol ID
- 6909
- Status last verified
- Nov 2021
- First submitted
- 3 Sep 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT05037994
- Acronym / sponsor ID
- 6909
- Conditions
- Pain, Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (C Group) | Placebo comparator | Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcainePatients will receive continuous US suprascapular nerve block only. |
| Gabapentin Group (G Group) | Experimental | Procedure: Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcainePatients will receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2
- ASA I, II or III.
- Cooperative patients.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaineAlso: Oral gabapentin 300 mg at bed time in GGThe 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. | Procedure or surgery | Control Group (C Group), Gabapentin Group (G Group) |
Primary outcome
Visual analogue scale
Time frame: 6 weeks
10cm line where zero means no pain and ten means worse imaginary pain
2 secondary outcomes
Range of passive and active movements
Time frame: 6 weeks
Patients satisfaction
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMAD S HEGAB, MD study director
Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine in people with Pain, Shoulder, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.