Postoperative PainNCT03660020
Ultrasound Guided Erector Spinae Plane Block in Breast Surgery
A study testing Local anesthetic and Hyaluronidase in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Local anesthetic and Hyaluronidase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2018to Dec 2020
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- ASA I, II, III
- Elective surgery
Who cannot join
- Patient refusal
- Infection at injection site
- Allergy to the given drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71111
mohammed Ali Ahmed, MD, amira_salem2015@yahoo.com
About this study
Official title: Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope
Read the detailed description
two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.
- Conditions
- Postoperative Pain
- Being tested
- Local anesthetic, Hyaluronidase
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anestheticDrug
ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only
HyaluronidaseDrug
hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy
| Study group | Role | What they receive |
|---|---|---|
| local anaesthetic group | Sham comparator | Not described Receives: Drug: Local anesthetic |
| hyalorounidase group | Active comparator | Not described Receives: Drug: Hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of local anaesthetics spread after injection in both group
spread of local anaesthics will be examined under floroscopic guide
Measured: 10 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start19 May 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (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 Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
- Investigators
- saeid elsawy, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660020
- Sponsor's protocol ID
- NBBL
- Status last verified
- Apr 2020
- First submitted
- 20 Jul 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT03660020
- Acronym / sponsor ID
- NBBL
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 May 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Sep 2018 (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.
hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope
Detailed description
two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anaesthetic group | Sham comparator | Drug: Local anesthetic |
| hyalorounidase group | Active comparator | Drug: Hyaluronidase |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- ASA I, II, III
- Elective surgery
Key exclusion criteria (3 listed)
- Patient refusal
- Infection at injection site
- Allergy to the given drugs
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 |
|---|---|---|
| Local anestheticultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only | Drug | local anaesthetic group |
| Hyaluronidasehyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy | Drug | hyalorounidase group |
Primary outcome
degree of local anaesthetics spread after injection in both group
Time frame: 10 minutes after block
spread of local anaesthics will be examined under floroscopic guide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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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.
saeid elsawy study chair
Assiut 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 Local anesthetic and Hyaluronidase in people with Postoperative Pain, run by Assiut 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 3 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 9 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rasha HAMED (088-01000440773, rashaahmed11@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of local anaesthetics spread after injection in both group (time frame: 10 minutes after block). 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 9 Apr 2020.