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Clinical Trials/NCT04396561
NCT04396561
Completed
Phase 4

Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study

Cairo University1 site in 1 country60 target enrollmentJanuary 20, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Unilateral U/S PVB
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Total intraoperative fentanyl consumption.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction.

Detailed Description

Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use. It can provide greater overall comfort with lower pain scores and greater tolerance of physical activity during the initial postoperative period. Ultrasound imaging has revolutionized the practice of regional anesthesia in that the operator can visualize and identify the paravertebral space, needle during its passage through the tissues, as well as deposition and spread of local anesthetic into the desired spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration with the added advantage of decrease in drug dosage, reduction in incidence of local anesthetic toxicity, increase success rate, reduction in procedure pain and better patient satisfaction. To the best of researchers' knowledge, evaluation of unilateral ultrasound guided paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer patients was not investigated before.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
June 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Physical status ASA II and III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m
  • Patient undergoing lower limb-sparing surgery for cancer surgeries under general anesthesia.

Exclusion Criteria

  • Patient refusal.
  • Known sensitivity or contraindication to local anesthetics.
  • History of psychological disorders and/or chronic pain.
  • Coagulopathies with INR ≥1.5: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with PC less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).
  • Significant liver or renal insufficiency.
  • Localized infection at the site of block.

Outcomes

Primary Outcomes

Total intraoperative fentanyl consumption.

Time Frame: 24 hours

Total intraoperative fentanyl consumption.

Secondary Outcomes

  • Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.(24 hours)
  • Heart rate and mean arterial blood pressure .(24 hours)
  • Morphine consumption postoperatively for 24 hours..(24 hours Postoperative)

Study Sites (1)

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