Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Thoracotomy

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05885230
Collaborator
(none)
138
1
2
12
11.5

Study Details

Study Description

Brief Summary

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-thoracotomy pain syndrome (PTPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after thoracotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PTPS .

Condition or Disease Intervention/Treatment Phase
  • Procedure: pecto intercostal fascial block using bupivacaine 0.25%
  • Drug: lidocaine infusion
N/A

Detailed Description

Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.

Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PTPS

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Efficacy of Ultrasound-guided Pecto-Intercostal Fascial Plain Block Versus Lidocaine Infusion on Acute and Chronic Post-thoracotomy Pain; A Prospective Randomized Controlled Trial
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PIFB group

patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.

Procedure: pecto intercostal fascial block using bupivacaine 0.25%
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.
Other Names:
  • Sunnypivacaine
  • Active Comparator: LIDOCAINE group

    1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.

    Drug: lidocaine infusion
    1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.
    Other Names:
  • Lignocaine
  • Outcome Measures

    Primary Outcome Measures

    1. Total dose of morphine in the first 24 h postoperatively. [24 hours postoperative]

      total morphine consumed in the first 24 hour

    Secondary Outcome Measures

    1. NRS numerical rating scale. [24 hours post operative]

      NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief

    2. chronic postoperative pain in 3 and/or 6 months after operation according to numerical rating scale [within 3 to 6 months postoperative]

      NRS ranging from grade 0 (no pain) to grade 10 (most severe pain) NRS< 4 is acceptable for pain relief

    3. Time to rescue analgesic [within 24 hour postoperative]

      time from extubation to the time the patiants given analgesia

    4. time to extubation [within 24 hour post operative]

      from end of surgery to the time of extubation

    5. length of intensive care stay [within one week]

      from end of surgery to the time of discharging to the surgical word

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. age between 18 and 75 years.

    2. patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.

    3. American Society of Anesthesiologists classification of physical status < IV.

    Exclusion Criteria:
    1. emergency surgery.

    2. off-pump surgery.

    3. redo surgery.

    4. ejection fraction less than 35%.

    5. refusal of the patient.

    6. known hypersensitivity to LA.

    7. chronic opioid use or chronic pain patient.

    8. psychiatric problems or communication difficulties.

    9. liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).

    10. renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).

    11. obstructive sleep apnea syndrom.

    12. coexisting hematologic disorders.

    13. pregnancy or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benisuef University Hospital Banī Suwayf e\EYGPT Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Mariana A mansour, Lecturer, benisuef university hospital,Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariana Soliman, Lecturer of anaesthesia, surgical intensive care and pain managment, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05885230
    Other Study ID Numbers:
    • FMBSUREC/09042023/Mikhael
    First Posted:
    Jun 1, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2023