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

NCT05885230 | Recruiting

• 1 other identifier: FMBSUREC/09042023/Mikhael
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Total dose of morphine in the first 24 h postoperatively.

  total morphine consumed in the first 24 hour

  24 hours postoperative

Secondary Outcomes (5)

• NRS numerical rating scale.

  24 hours post operative

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

  within 3 months postoperative

• Time to rescue analgesic

  within 24 hour postoperative

• time to extubation

  within 24 hour post operative

• length of intensive care stay

  within one week

Study Arms (2)

PIFB group

ACTIVE COMPARATOR

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%

LIDOCAINE group

ACTIVE COMPARATOR

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

Interventions

pecto intercostal fascial block using bupivacaine 0.25% PROCEDURE

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

Also known as: Sunnypivacaine

PIFB group

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.

Also known as: Lignocaine

LIDOCAINE group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• emergency surgery.
• off-pump surgery.
• redo surgery.
• ejection fraction less than 35%.
• refusal of the patient.
• known hypersensitivity to LA.
• chronic opioid use or chronic pain patient.
• psychiatric problems or communication difficulties.
• liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
• renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min).
• obstructive sleep apnea syndrom.
• coexisting hematologic disorders.
• pregnancy or breastfeeding.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Benisuef University Hospital

Banī Suwayf, e\EYGPT, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mariana A mansour, Lecturer

  benisuef university hospital,Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana A soliman, lecturer

CONTACT

01222960009; mrmrsyk4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia, surgical intensive care and pain managment

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

EG (1)