Open Nephrectomy, Postoperative Analgesia, Subtransverse Interligamentary Block, Thoracic Paravertebral Block
Conditions
Brief summary
This study aims to compare ultrasound-guided subtransverse process interligamentary (STIL) block versus thoracic paravertebral block (TPVB) for postoperative analgesia in patients undergoing open nephrectomy.
Detailed description
Acute pain physiopathology is explained as it is mediated by inflammatory cell infiltration, activation of spinal cord pain pathways, and also by reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery. A thoracic paravertebral block (TPVB) shows comparable analgesic efficacy with fewer side effects compared with thoracic epidural analgesia in patients undergoing thoracotomy. The recently introduced subtransverse process interligamentary (STIL) block offers a safer alternative by targeting thoracic nerves without entering paravertebral space.
Interventions
OTHERSubtransverse process interligamentary
Patients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%.
OTHERThoracic paravertebral block
Patients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-III. * Undergoing open nephrectomy under general anesthesia.
Exclusion criteria
* History of allergies to local anesthetics. * Opioid dependency. * Bleeding or coagulation disorders. * Psychiatric and neurological disorder. * Local infection at the site of injection. * Body mass index (BMI) \> 35 kg/m2. * Severe heart, lung, liver, and renal dysfunction. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 48 hours postoperatively | Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the 1st rescue analgesia | 48 hours postoperatively | Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated. |
| Intraoperative fentanyl consumption | Intraoperatively | Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). |
| Mean arterial pressure | Till the end of surgery (Up to 2 hours) | Mean arterial pressure will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery. |
| Heart rate | Till the end of surgery (Up to 2 hours) | Heart rate will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery. |
| Degree of pain | 48 hours postoperatively | Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 2, 4, 6, 8, 12, 18, 24, 36, and 48 h postoperatively. |
| Incidence of adverse events | 48 hours postoperatively | Incidence of adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, pruritus, or any other complication will be recorded. |
Countries
Egypt
Outcome results
None listed