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Completed

NCT Number: NCT04396561

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physical status ASA II and III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
  • 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.

Treatment and study plan

Paravertebral group (group P):

Drug

In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals.

Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.

Other names: Control group (group C):

Primary outcomes

  1. Total intraoperative fentanyl consumption.

    Time frame: 24 hours

    Total intraoperative fentanyl consumption.

Secondary outcomes

  1. Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.

    Time frame: 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.

  2. Heart rate and mean arterial blood pressure .

    Time frame: 24 hours

    Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)

  3. Morphine consumption postoperatively for 24 hours..

    Time frame: 24 hours Postoperative

    Morphine consumption per mg postoperatively for 24 hours..

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 20, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.