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Completed

NCT Number: NCT05363540

Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery

Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.

many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.

Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 20-70 years,
  • Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).

Exclusion criteria

  • Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
  • patients who have previous cardiac surgery,
  • prolonged CPB time (CPB>120 minutes),
  • Intubation time more than 12hrs or planned for overnight ventilation.
  • Allergy to any of used drugs,
  • opioids addiction,
  • Chronic liver disease, chronic renal disease, and cognitive impairment.

Treatment and study plan

pre-incisional parasternal intercostal block

Procedure

LA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used

post-incisional parasternal intercostal block

Procedure

LA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used.

Primary outcomes

  1. Amount of rescue analgesia

    Time frame: 24 hours postoperative

    Total amount of opioid administered as rescue analgesia postoperative.

Secondary outcomes

  1. Intraoperative total fentanyl requirements

    Time frame: during surgery

    the amount of consumed opioid during the procedure

  2. intraoperative mean arterial blood pressure (MAP)

    Time frame: during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)

    hemodynamic variability due to surgical stimulation

  3. pain score (VAS)

    Time frame: at extubation, 12th, 16th, 20th, and 24th hour postoperative

    VAS scores will be recorded by making a handwritten mark on a 10-cm line that represented a continuum between "no pain" and "worst possible pain."

  4. adverse effects

    Time frame: 24 hours postoperative

    nausea, vomiting, excessive sedation, respiratory depression

  5. patient satisfaction

    Time frame: 28 hours postoperative

    0 "extremely unsatisfied" to 10 "extremely satisfied"

  6. Intensive Care Unit (ICU) Length of Stay

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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