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

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

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.

Study Overview

• Status: Completed
• Conditions: Unilateral U/S PVB
• Intervention / Treatment: Drug: Paravertebral group (group P):

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paravertebral group (group P): After induction of general anesthesia and stabilization of the patients, they were positioned in lateral decubitus position with the side to be blocked uppermost.	Drug: Paravertebral group (group P): 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):
Experimental: Control group (group C): Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia (IV fentanyl 2 μcg/kg at induction and 1 gm of IV paracetamol).	Drug: Paravertebral group (group P): 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):

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative fentanyl consumption.	Total intraoperative fentanyl consumption.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analouge Scale at 0 , 4 , 8 ,12 ,24 hours postoperatively.	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.	24 hours
Heart rate and mean arterial blood pressure .	Heart rate(beat per minutes) and mean arterial blood pressure(mm HG)	24 hours
Morphine consumption postoperatively for 24 hours..	Morphine consumption per mg postoperatively for 24 hours..	24 hours Postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Enas Mohamed Samir, M.D, Cairo University; Study Director: Walaa Y Elsabeeny, M.D, National Cancer Institute, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MS-270-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Until ending the investigator's work

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes