Rhomboid Intercostal BlockEarly Phase 1NCT04859803
Rhomboid Intercostal and Sub-serratus Block
A Early Phase 1 study testing Patients will be received rhomboid intercostal block under ultrasound guidance. and conventional intravenous analgesia in people with Rhomboid Intercostal Block, run by Cairo University at 1 site in Egypt.
Trial summary
The rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by Elsharkawy et al. . Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rhomboid Intercostal Block
- What is being tested?
- Patients will be received rhomboid intercostal block under ultrasound guidance. and conventional intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 2 Nov 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Inclusion criteria Adult patients between 18-50 years. ASA physical status I and II Male gender
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
Official title: Efficacy of Rhomboid Intercostal Block With Sub-serratus Block on Perioperative Analgesia in Patients Undergoing Gynecomastia Surgery
The rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by Elsharkawy et al. . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia. However, the analgesic effects of the RISS block after breast surgery have not been analyzed through a randomized-controlled trial.
- Conditions
- Rhomboid Intercostal Block
- Being tested
- Patients will be received rhomboid intercostal block under ultrasound guidance., conventional intravenous analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be received rhomboid intercostal block under ultrasound guidance.Procedure or surgery
Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously [8]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH \& Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.
conventional intravenous analgesiaDrug
Following endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings
| Study group | Role | What they receive |
|---|---|---|
| RISS group | Active comparator | patients will receive rhomboid intercostal block under ultrasound guidance. Receives: Procedure: Patients will be received rhomboid intercostal block under ultrasound guidance. |
| Control group | Active comparator | Patients will received the conventional intravenous analgesia Receives: Drug: conventional intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Postoperative morphine consumption
Measured: 24 hours
Secondary outcomes (3)
recovery time
The time from stopping anaesthetic agent until extubation
Measured: 1 hour
Pain evaluation
Pain evaluation using the visual analog scale score,, 0= pain , 10= sever pain
Measured: 24 hous
time to first analgesia
duration of block
Measured: 24 hous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2021
- Primary completion25 Sep 2023
- Study completion2 Nov 2023
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
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
- NCT04859803
- Sponsor's protocol ID
- N-30-2021
- Status last verified
- Dec 2023
- First submitted
- 22 Apr 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still work
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rhomboid Intercostal Block With Sub-serratus Block on Perioperative Analgesia in Patients Undergoing Gynecomastia Surgery
- ClinicalTrials.gov ID
- NCT04859803
- Acronym / sponsor ID
- N-30-2021
- Conditions
- Rhomboid Intercostal Block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 26 Apr 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 rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by Elsharkawy et al. . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia. However, the analgesic effects of the RISS block after breast surgery have not been analyzed through a randomized-controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RISS group | Active comparator | Procedure: Patients will be received rhomboid intercostal block under ultrasound guidance.patients will receive rhomboid intercostal block under ultrasound guidance. |
| Control group | Active comparator | Drug: conventional intravenous analgesiaPatients will received the conventional intravenous analgesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- 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 |
|---|---|---|
| Patients will be received rhomboid intercostal block under ultrasound guidance.Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously [8]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH \& Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. | Procedure or surgery | RISS group |
| conventional intravenous analgesiaFollowing endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings | Drug | Control group |
Primary outcome
morphine consumption
Time frame: 24 hours
Postoperative morphine consumption
3 secondary outcomes
recovery time
Time frame: 1 hour
Pain evaluation
Time frame: 24 hous
time to first analgesia
Time frame: 24 hous
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 12 Dec 2023.
- Individual participant dataSharing planned: Undecided. still work
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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 Patients will be received rhomboid intercostal block under ultrasound guidance. and conventional intravenous analgesia 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: finished, as of the sponsor's last update on 12 Dec 2023. 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 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?
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?
morphine consumption (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 12 Dec 2023.