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Recruiting NCT05833048

Rectus Sheath Block in Cardiac Surgery

No phase Interventional Cardiac Disease Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rectus sheath block.
Who it may be relevant to
Registry conditions: Cardiac Disease, Postoperative Pain. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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. 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.

Interventions

  • Procedure Rectus sheath block
    Participants will receive an ultrasound guided rectus sheath block with local anesthetic

Primary outcome measures

  • Opioid consumption [Time frame: 72 hours postoperatively]
  • VAS pain scores [Time frame: 72 hours postoperatively]
Secondary outcome measures (3)
  • Length of stay in ICU [Time frame: 72 hours]
  • Length of hospital stay [Time frame: 72 hours]
  • Time to extubation [Time frame: 72 hours]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai Morningside Hospital Center — New York

Identifiers

NCT: NCT05833048 · STUDY-23-00096

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗