Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
Primary Purpose
Stone, Kidney
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single shot ESBP with dexmedtomidine
continous ESPB
Sponsored by
About this trial
This is an interventional other trial for Stone, Kidney
Eligibility Criteria
Inclusion Criteria:
- Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy
Exclusion Criteria:
- - Body mass index greater than 35 kg/m2.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A (single shot,n=20)
Group B (continous infusion,n=20)
Arm Description
Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB
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
Outcomes
Primary Outcome Measures
Duration of postoperative Analgesia:
"the time interval between extubation and the first request to postoperative analgesia
Secondary Outcome Measures
Duration of sensory block
the time interval between the onset of successful sensory block and the first request to postoperative analgesia
Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
visual analogue scale during rest and movement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04650737
Brief Title
Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
Official Title
Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The current study is designed to assess the efficacy of a single shot ESPB with Dexmedetomidineversus continuous ESPB in perioperative analgesia for PCNL. Both techniques are conducted for patients undergoing PCNL under GA.
Detailed Description
Successful perioperative pain management is one of the main goals of the whole anesthetic practice. Kidney Surgeries, especially those involving the renal pelvis warrant special analgesic considerations. This is due to the sensitivity of the renal pelvis to pain. Its sub-diaphragmatic position affects deep breathing and coughing. Which renders adequate analgesia an important factor for maintaining good respiratory force and depth postoperative and reduces respiratory complications like atelectasis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both groups will receive Ultrasound guided ESPB before induction of general anesthesia
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
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (single shot,n=20)
Arm Type
Active Comparator
Arm Description
Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB
Arm Title
Group B (continous infusion,n=20)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
single shot ESBP with dexmedtomidine
Intervention Description
Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
continous ESPB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of postoperative Analgesia:
Description
"the time interval between extubation and the first request to postoperative analgesia
Time Frame
post-operative period(24 hours)
Secondary Outcome Measure Information:
Title
Duration of sensory block
Description
the time interval between the onset of successful sensory block and the first request to postoperative analgesia
Time Frame
24 hours
Title
Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
Description
visual analogue scale during rest and movement
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy
Exclusion Criteria:
- Body mass index greater than 35 kg/m2.
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29885165
Citation
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.
Results Reference
background
PubMed Identifier
8017600
Citation
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.
Results Reference
background
PubMed Identifier
29288788
Citation
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.
Results Reference
background
PubMed Identifier
19602964
Citation
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.
Results Reference
background
PubMed Identifier
22762468
Citation
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.
Results Reference
background
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Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
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