Clinical trial NCT04396561: Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
Official title: Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unilateral U/S PVB
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled double-blind study.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patient refusal.
2. Known sensitivity or contraindication to local anesthetics.
3. History of psychological disorders and/or chronic pain.
4. 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).
5. Significant liver or renal insufficiency.
6. Localized infection at the site of block.

Primary outcomes:
measure: Total intraoperative fentanyl consumption.
timeFrame: 24 hours
Secondary outcomes:
measure: Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.
timeFrame: 24 hours
measure: Heart rate and mean arterial blood pressure .
timeFrame: 24 hours
measure: Morphine consumption postoperatively for 24 hours..
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
affiliation: Cairo University
name: Ahmed Abdalla Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Enas Mohamed Samir, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, M.D
role: STUDY_DIRECTOR
References: