Postoperative PainPhase 1/2NCT04183244
Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery
A Phase 1/2 study testing Erector spinae block and Infraclavicular subomohyoid (ISO) block in people with Postoperative Pain and Shoulder Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Shoulder Pain
- What is being tested?
- Erector spinae block and Infraclavicular subomohyoid (ISO) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2019to 15 Feb 2021
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, above 18 years old.
- ASA physical status I
- Scheduled for shoulder surgery
Who cannot join
- Morbid obese.
- Previous surgery in the same shoulder.
- History of psychiatric disorder.
- Pulmonary disease.
- Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
- Allergy to any of medications that will be used
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Randa Ali Shoukry
Cairo, Al-Nozha, 11843
Randa A Shoukry, MD, 01001404426, randa_shoukry@hotmail.com
Mona R Hosny, MD, 01001540563, monamourmar@hotmail.com
About this study
Official title: Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study
The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively will be recorded.
- Conditions
- Postoperative Pain, Shoulder Pain
- Being tested
- Erector spinae block, Infraclavicular subomohyoid (ISO) block
- Keywords
- Erector Spinae Plane Block, Infraclavicular Subomohyoid Block, Shoulder Surgery
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae blockProcedure or surgery
A 5-cm needle prick in the back of the patient 3 cm lateral to mid-line under sterile conditions, with ultrasound guidance.
Infraclavicular subomohyoid (ISO) blockProcedure or surgery
Under complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae block | Active comparator | Ultrasound guidance will be used to visualize the transverse processes of T2 and the overlying muscles.
Under sterile conditions, a 5-cm, 21-gauge needle will be inserted using the out-of-plane technique parallel to the sagittal plane directly over the transverse process,then 30mL of the local anesthetic solution will be injected and observed for the linear spread of LA the under direct ultrasound visualization Receives: Procedure: Erector spinae block |
| infraclavicular subomohyoid block | Active comparator | Performing posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance. Receives: Procedure: Infraclavicular subomohyoid (ISO) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The block efficacy
Percentage of 24 hours pain free patients
Measured: 24 hours
Secondary outcomes (1)
The incidence of expected complications ( Block safety)
The incidence of expected complications such as phrenic nerve palsy or pneumothorax.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start15 Aug 2019
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Ali Shoukry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183244
- Sponsor's protocol ID
- FMASU R 57/2019
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2019
- Last updated
- 16 Dec 2020
- 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 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery: A Randomized Controlled Blinded Study
- ClinicalTrials.gov ID
- NCT04183244
- Acronym / sponsor ID
- FMASU R 57/2019
- Conditions
- Postoperative Pain, Shoulder Pain
- Keywords
- Erector Spinae Plane Block, Infraclavicular Subomohyoid Block, Shoulder Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 3 Dec 2019 (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 study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae block | Active comparator | Procedure: Erector spinae blockUltrasound guidance will be used to visualize the transverse processes of T2 and the overlying muscles. Under sterile conditions, a 5-cm, 21-gauge needle will be inserted using the out-of-plane technique parallel to the sagittal plane directly over the transverse process,then 30mL of the local anesthetic solution will be injected and observed for the linear spread of LA the under direct ultrasound visualization |
| infraclavicular subomohyoid block | Active comparator | Procedure: Infraclavicular subomohyoid (ISO) blockPerforming posterior approach infraclavicular BP block followed by subomohioid block via the same puncture site under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, above 18 years old.
- ASA physical status I
- Scheduled for shoulder surgery
Key exclusion criteria (6 listed)
- Morbid obese.
- Previous surgery in the same shoulder.
- History of psychiatric disorder.
- Pulmonary disease.
- Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
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 |
|---|---|---|
| Erector spinae blockA 5-cm needle prick in the back of the patient 3 cm lateral to mid-line under sterile conditions, with ultrasound guidance. | Procedure or surgery | Erector spinae block |
| Infraclavicular subomohyoid (ISO) blockUnder complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance. | Procedure or surgery | infraclavicular subomohyoid block |
Primary outcome
The block efficacy
Time frame: 24 hours
Percentage of 24 hours pain free patients
1 secondary outcome
The incidence of expected complications ( Block safety)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Erector spinae block and Infraclavicular subomohyoid (ISO) block in people with Postoperative Pain and Shoulder Pain, run by Ain Shams 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 6 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randa A Shoukry (002 01001404426, randa_shoukry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The block efficacy (time frame: 24 hours). 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 Dec 2020.