Unilateral U/S PVB
Conditions
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.
Interventions
DRUGParavertebral 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
sealed opaque envelopes prepared by an assistant blinded about the study targets and chosen by patient him/herself, allocated into two groups
Intervention model description
Prospective randomized controlled double-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative fentanyl consumption. | 24 hours | Total intraoperative fentanyl consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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.. |
Countries
Egypt
Outcome results
None listed