Rhomboid Intercostal BlockEarly Phase 1NCT05301075
Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery
A Early Phase 1 study testing Rhomboid Intercostal and Sub-Serratus block in people with Rhomboid Intercostal Block, run by Cairo University at 1 site in Egypt.
Trial summary
Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhomboid Intercostal Block
- What is being tested?
- Rhomboid Intercostal and Sub-Serratus block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2022to 30 Aug 2023
- Phase
- Early Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion criteria Adult patients between 18-60 years. Genders eligible for study: both sexes ASA physical status I and II Undergoing open nephrectomy surgery
- Exclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV
Trial locations and contacts
1 site in 1 country.
About this study
Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes
- Conditions
- Rhomboid Intercostal Block
- Being tested
- Rhomboid Intercostal and Sub-Serratus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal and Sub-Serratus blockDrug
Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | patients will receive sham block. Receives: Drug: Rhomboid Intercostal and Sub-Serratus block |
| RISS group | Active comparator | will receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance Receives: Drug: Rhomboid Intercostal and Sub-Serratus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
nalbuphine consumption i
Postoperative nalbuphine consumption
Measured: 24 hours
Secondary outcomes (2)
nalbuphine consumption.
intraoperative nalbuphine consumption.
Measured: 2 hours
Patient's satisfaction
using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent;
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 posted29 Mar 2022
- Study start21 Mar 2022 (estimated)
- Primary completion13 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhomboid Intercostal BlockStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301075
- Sponsor's protocol ID
- N-74-2021
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhomboid Intercostal and Subserratus Plane (RISS) Block on Postoperative Painafter Open Nephrectomy Surgery
- ClinicalTrials.gov ID
- NCT05301075
- Acronym / sponsor ID
- N-74-2021
- Conditions
- Rhomboid Intercostal Block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (estimated)
- Primary completion
- 13 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 29 Mar 2022 (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.
Rhomboid intercostal block (RIB) is a new interfascial plane block describe by Elsharkawy et al. in 2016. The region described is understood because the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anaesthetic drug is run between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Drug: Rhomboid Intercostal and Sub-Serratus blockpatients will receive sham block. |
| RISS group | Active comparator | Drug: Rhomboid Intercostal and Sub-Serratus blockwill receive Rhomboid Intercostal and Sub-Serratus block under ultrasound guidance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Rhomboid Intercostal and Sub-Serratus blockRhomboid Intercostal and Sub-Serratus block under ultrasound guidance | Drug | RISS group, control group |
Primary outcome
nalbuphine consumption i
Time frame: 24 hours
Postoperative nalbuphine consumption
2 secondary outcomes
nalbuphine consumption.
Time frame: 2 hours
Patient's satisfaction
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 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. still working
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rhomboid Intercostal and Sub-Serratus block in people with Rhomboid Intercostal Block, run by Cairo 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?
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 29 Mar 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
nalbuphine consumption i (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 29 Mar 2022.