Cardiac DiseaseNCT05833048
Rectus Sheath Block in Cardiac Surgery
A study testing Rectus sheath block in people with Cardiac Disease and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. 1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery? 2. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Disease, Postoperative Pain
- What is being tested?
- Rectus sheath block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving chest tubes
- Male or female
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- ASA class V
- Urgent or emergent surgery
- Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- History of substance abuse or chronic opioid use
- Patient refusal or inability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Morningside Hospital Center
New York, New York, 10023
Ali Shariat, MD, 212-523-2500, AliNima.Shariat@mountsinai.org
About this study
This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block.
- Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery?
- Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.
- Conditions
- Cardiac Disease, Postoperative Pain
- Being tested
- Rectus sheath block
- Keywords
- cardiac surgery, regional anesthesia
- Medical subject headings
- Heart Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath blockProcedure or surgery
Participants will receive an ultrasound guided rectus sheath block with local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Block | Experimental | Not described Receives: Procedure: Rectus sheath block |
| No block | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Amount of opioid consumption required postoperatively
Measured: 72 hours postoperatively
VAS pain scores
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
Measured: 72 hours postoperatively
Secondary outcomes (3)
Length of stay in ICU
Amount of time spent in ICU postoperatively
Measured: 72 hours
Length of hospital stay
Length of time spent in hospital postoperatively
Measured: 72 hours
Time to extubation
Length of time requiring postoperative mechanical ventilation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start29 Jul 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nima Shariat, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833048
- Sponsor's protocol ID
- STUDY-23-00096
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectus Sheath Block in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05833048
- Acronym / sponsor ID
- STUDY-23-00096
- Conditions
- Cardiac Disease, Postoperative Pain
- Keywords
- cardiac surgery, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Apr 2023 (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.
This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block.
- Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery?
- Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Block | Experimental | Procedure: Rectus sheath block |
| No block | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| Rectus sheath blockParticipants will receive an ultrasound guided rectus sheath block with local anesthetic | Procedure or surgery | Rectus Sheath Block |
Primary outcome
Opioid consumption
Time frame: 72 hours postoperatively
Amount of opioid consumption required postoperatively
VAS pain scores
Time frame: 72 hours postoperatively
VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively
3 secondary outcomes
Length of stay in ICU
Time frame: 72 hours
Length of hospital stay
Time frame: 72 hours
Time to extubation
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus sheath block in people with Cardiac Disease and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Shariat, MD (212-523-2500, AliNima.Shariat@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 72 hours postoperatively). 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 31 Jul 2026.