AnesthesiaNCT04821947
Rhomboid Intercostal Plane Block vs Local Anesthetic Infilteration for Postoperative Analgesia After Thoracoscopic Surgery
A study testing Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine in people with Anesthesia, run by Ain Shams University.
Trial summary
The purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA ) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I \&II
Who cannot join
- Allergic constitution
- Severe cardiovascular or hepatorenal insufficiency
- Coagulation system disease
- Injection site infection
- Morbid obesity (BMI>40 kg/m2).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Rhomboid Intercostal Plane Block for Postoperative Analgesia After Thoracoscopic Surgery Compared With Local Anesthetic Infilteration: A Randomized Clinical Trial
The purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA )
- Conditions
- Anesthesia
- Being tested
- Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% BupivacaineOther
for RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula.
After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| RIB Group | Active comparator | Drug: Bupivacaine 0.25% patients will receive 20 ml of bupivacaine 0.25% in the rhomboid plane under rhomboid major muscle Receives: Other: Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine |
| LA Group | Active comparator | Drug: Bupivacaine 0.25% patients will receive wound infiltration of VATS incision, single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine . Receives: Other: Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of postoperative analgesic consumption
total dose of postoperative tramadol and morphine
Measured: First 24 hours postoperative
Visual Analogue Score ( VAS )
VAS will be measured at 1st, 2nd, 4th, 6th, 12th, 24th hours postoperative at rest and during cough
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Other
- 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
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821947
- Sponsor's protocol ID
- FMASU R 34/2021
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhomboid Intercostal Plane Block for Postoperative Analgesia After Thoracoscopic Surgery Compared With Local Anesthetic Infilteration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04821947
- Acronym / sponsor ID
- FMASU R 34/2021
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 30 Mar 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 purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA )
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIB Group | Active comparator | Other: Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% BupivacaineDrug: Bupivacaine 0.25% patients will receive 20 ml of bupivacaine 0.25% in the rhomboid plane under rhomboid major muscle |
| LA Group | Active comparator | Other: Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% BupivacaineDrug: Bupivacaine 0.25% patients will receive wound infiltration of VATS incision, single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA status I \&II
Key exclusion criteria (5 listed)
- Allergic constitution
- Severe cardiovascular or hepatorenal insufficiency
- Coagulation system disease
- Injection site infection
- Morbid obesity (BMI>40 kg/m2).
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 plane block or Local anesthetic infiltration of 0.25% Bupivacainefor RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula. After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine | Other | LA Group, RIB Group |
Primary outcome
Total amount of postoperative analgesic consumption
Time frame: First 24 hours postoperative
total dose of postoperative tramadol and morphine
Visual Analogue Score ( VAS )
Time frame: First 24 hours postoperative
VAS will be measured at 1st, 2nd, 4th, 6th, 12th, 24th hours postoperative at rest and during cough
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine in people with Anesthesia, run by Ain Shams University.
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 1 inclusion and 5 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Heba Fouad, MD (01221077317 ext. 002, heba.toulan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of postoperative analgesic consumption (time frame: First 24 hours postoperative). The study lists 2 primary outcomes in all. 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 30 Mar 2021.