Comparing two pain management techniques for cardiac surgery
Role of Transversus Thoracis Plane Block Versus Parasternal Intercostal Nerve Plane Block in Enhanced Recovery Program After Cardiac Surgery: A Randomized Controlled Study
NA · Zagazig University · NCT06155097
This study is testing two different pain management techniques to see which one helps patients recover better after heart surgery while using fewer opioids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Zagazig University (other gov) |
| Locations | 1 site (Zagazig, Elsharqya) |
| Trial ID | NCT06155097 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two regional anesthesia techniques, the transversus thoracis muscle plane block (TTP) and the parasternal intercostal nerve block (PSI), in managing postoperative pain for patients undergoing elective cardiac surgery. The goal is to reduce reliance on opioid analgesics, which can have significant side effects that hinder recovery. By implementing a multimodal pain management approach, the study aims to enhance recovery after surgery (ERAS) and improve overall patient outcomes. The research will involve patients aged 21-60 who meet specific health criteria and will assess pain relief and recovery metrics post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21-60 undergoing elective cardiac surgeries that require median sternotomy and who have a body mass index greater than 35.
Not a fit: Patients who may not benefit include those with major organ dysfunction, cognitive impairments, or those undergoing emergency surgeries.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that enhance recovery and reduce opioid-related side effects for cardiac surgery patients.
How similar studies have performed: Other studies have shown promise in using regional anesthesia techniques for pain management in cardiac surgery, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient acceptance. * Sex: both; male and female * Age (21-60) years old. * American society of anesthesiology (ASA): II and III. * Body mass index (BMI) \>35 kg/m2 * Elective cardiac surgeries requiring median sternotomy. * Accepted mental state of the patient. * Non-smoker or ex-smoker for more than one month. * Optimal preoperative glycemic control, defined by a hemoglobin A1c level less than 6.5%. Exclusion Criteria: * Patient refusal and lack of informed consent. * Emergency or non-median sternotomy surgery. * History of allergy to local anesthetics (lidocaine or bupivicaine). * Coexisting hematologic disorders or malnourished patient. * Pre-existing major organ dysfunction including hepatic or renal failure, and left ventricular ejection fraction \<30% * Peripheral neuropathy. * Pregnancy. * Patients with a diagnosis of cognitive impairment. * Significant psychiatric illnesses including schizophrenia, bipolar disorder, uncontrolled anxiety, or depression.
Where this trial is running
Zagazig, Elsharqya
- faculty of medicine, Zagazig university — Zagazig, Elsharqya, Egypt (RECRUITING)
Study contacts
- Study coordinator: Rehab A Wahdan, MD
- Email: obz13w@yahoo.com
- Phone: 01003481323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Surgery, postcardiac surgery, transversus thoracis muscle plane block, parasternal intercostal nerve block, Enhanced recovery after surgery