Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
NCT ID: NCT04650737
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-12-01
2021-12-29
Brief Summary
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Detailed Description
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The Use of a single mode of analgesia in these settings , like the use of parenteral opioids for example, provides significantly less analgesic effect and more complications including respiratory depression , PONV (postoperative nausea and vomiting ) , constipation , urine retention …etc.
The use of regional techniques as a part of multimodal pain management in these procedures provides superior analgesia and less complication rates.
This is added to high expectations of an easier perioperative course of PCNL (percutaneous nephrolithotomy) being and endoscopic procedure that does not involve a big skin incision. These expectations also include a short hospital stay. However PCNL is usually associated with significant pain and discomfort postoperatively. Various studies have been studying effects of integrating local and regional techniques in the perioperative pain management.
For Regional and local procedures of analgesia; Studies of Single Shot technique and catheter techniques has long been ongoing for many regional techniques for example like Pravertebral block and adductor canal block . These studies are conducted to determine the efficacy and adversities each technique.
Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block . Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine . Peri-neural dexmedetomidine was evaluated in animal studies where it prolonged the duration of sensory and motor blocks of local anesthetics without any evidence of neurotoxicity for up to 14 days after initial administration . The use of perineuraldexmedetomidine prolong the duration of of sensory block, provide effective acute pain control after surgery and reduce the need for rescue analgesia in several nerve blocks like upper limb extremity blocks,Paravertebral block), tranversus abdominis plane (TAP) block and Erector spinae plane block.
Erector spinae plane block (ESPB) is a relatively novel procedure. The limited number of studies available show promising results as regards the efficacy of pain management in trunk surgeries and renal interventions. However the studies that clarify the different applications of ESPB, including the efficacy of a single shot versus a continuous block with an indwelling catheter, are lacking.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Single shot group (A):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine.
* Continous infusion group (B):(20 patients) Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs
OTHER
DOUBLE
Study Groups
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Group A (single shot,n=20)
Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB
single shot ESBP with dexmedtomidine
Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
Group B (continous infusion,n=20)
Patients in this group will receive 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs;ESPB
continous ESPB
Patients in this group will receive erector spine plane block with 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs.
Interventions
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single shot ESBP with dexmedtomidine
Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
continous ESPB
Patients in this group will receive erector spine plane block with 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy.
* Unstable coronary artery disease, congestive heart failure, or arrhythmias.
* Baseline heart rate (HR) less than 60 beats/min or baseline systolic blood pressure less than 100 mmHg.
* Pre-existing neurological deficits or neuropathy.
* Significant psychiatric or cognitive conditions interfering with consent or assessment.
* Significant renal impairment (creatinine above 2 mg/dl)
* Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
* Known contraindications to peripheral nerve block, including local skin infections, bleeding diathesis, and coagulopathy.
* Allergies to local anesthetics, dexmedetomidine, or any component of multimodal analgesia.
18 Years
50 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mina Adolf Helmy
Doctor
References
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Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
Schug SA, Fry RA. Continuous regional analgesia in comparison with intravenous opioid administration for routine postoperative pain control. Anaesthesia. 1994 Jun;49(6):528-32. doi: 10.1111/j.1365-2044.1994.tb03528.x.
Choi SW, Cho SJ, Moon HW, Lee KW, Lee SH, Hong SH, Choi YS, Bae WJ, Ha US, Hong SH, Lee JY, Kim SW, Cho HJ. Effect of Intercostal Nerve Block and Nephrostomy Tract Infiltration With Ropivacaine on Postoperative Pain Control After Tubeless Percutaneous Nephrolithotomy: A Prospective, Randomized, and Case-controlled Trial. Urology. 2018 Apr;114:49-55. doi: 10.1016/j.urology.2017.12.004. Epub 2017 Dec 27.
Popping DM, Elia N, Marret E, Wenk M, Tramer MR. Clonidine as an adjuvant to local anesthetics for peripheral nerve and plexus blocks: a meta-analysis of randomized trials. Anesthesiology. 2009 Aug;111(2):406-15. doi: 10.1097/ALN.0b013e3181aae897.
Farag E, Argalious M, Abd-Elsayed A, Ebrahim Z, Doyle DJ. The use of dexmedetomidine in anesthesia and intensive care: a review. Curr Pharm Des. 2012;18(38):6257-65. doi: 10.2174/138161212803832272.
Other Identifiers
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ESPB in nephrolithotomy
Identifier Type: -
Identifier Source: org_study_id