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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeni-Suef University

About this trial

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy 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 PSPS .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age between 18 and 75 years.

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

American Society of Anesthesiologists classification of physical status < IV.

Disqualifiers

emergency surgery.

off-pump surgery.

redo surgery.

ejection fraction less than 35%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • pecto intercostal fascial block using bupivacaine 0.25%

    Procedure/Surgery

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

  • lidocaine infusion

    Drug

    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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: PIFB groupActive comparator 1 intervention
Group B: LIDOCAINE groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total dose of morphine in the first 24 h postoperatively.

total morphine consumed in the first 24 hour

Time frame
24 hours postoperative

Secondary outcomes

1

NRS numerical rating scale.

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

Time frame
24 hours post operative
2

chronic postoperative pain in 3 months after operation according to numerical rating scale

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

Time frame
within 3 months postoperative
3

Time to rescue analgesic

time from extubation to the time the patiants given analgesia

Time frame
within 24 hour postoperative
4

time to extubation

from end of surgery to the time of extubation

Time frame
within 24 hour post operative

Other outcomes

Sponsors and contacts

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