Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients

Phase 4

Completed

• Conditions: Unilateral U/S PVB

• Registration Number: NCT04396561
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Status Verified: 2020-06
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-10
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total intraoperative fentanyl consumption.	24 hours	Total intraoperative fentanyl consumption.

Secondary Outcome Measures

Name	Time	Method
Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.	24 hours	Visual Analouge Scaleat 0 , 4 , 8 ,12 ,24 hours postoperatively.The VAS consists of a 10-cm line, with anchors at either end. One end is marked "no pain" and the other end is marked "the worst imaginable pain". The patient marks the place on the line to indicate his or her pain intensity. The clinician then measures the line with a ruler and assigns a score.
Heart rate and mean arterial blood pressure .	24 hours	Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)
Morphine consumption postoperatively for 24 hours..	24 hours Postoperative	Morphine consumption per mg postoperatively for 24 hours..

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed; 🇪🇬 Cairo, Egypt