Stone, KidneyNCT04650737
Single-Shot With Dexmedetomidine Versus Continuous Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control After Percutaneous Nephrolithotomy
A study testing single shot ESBP with dexmedtomidine and continous ESPB in people with Stone, Kidney, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- single shot ESBP with dexmedtomidine and continous ESPB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy
Who cannot join
- - 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Stone, Kidney
- Being tested
- single shot ESBP with dexmedtomidine, continous ESPB
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single shot ESBP with dexmedtomidineDrug
Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
continous ESPBDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (single shot,n=20) | Active comparator | Patients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB Receives: Drug: single shot ESBP with dexmedtomidine |
| Group B (continous infusion,n=20) | Active comparator | 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 Receives: Drug: continous ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative Analgesia:
"the time interval between extubation and the first request to postoperative analgesia
Measured: post-operative period(24 hours)
Secondary outcomes (2)
Duration of sensory block
the time interval between the onset of successful sensory block and the first request to postoperative analgesia
Measured: 24 hours
Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
visual analogue scale during rest and movement
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion29 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650737
- Sponsor's protocol ID
- ESPB in nephrolithotomy
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29885165Schug 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.
PubMed 8017600Choi 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.
PubMed 29288788Popping 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.
PubMed 19602964Farag 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.
PubMed 22762468
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04650737
- Acronym / sponsor ID
- ESPB in nephrolithotomy
- Conditions
- Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (single shot,n=20) | Active comparator | Drug: single shot ESBP with dexmedtomidinePatients in this group will receive 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine ;ultrasound guided ESPB |
| Group B (continous infusion,n=20) | Active comparator | Drug: continous ESPBPatients 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients of age (18-50), ASA physical status I or II undergoing unilateral percutaneous nephrolithotomy
Key exclusion criteria (10 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single shot ESBP with dexmedtomidinePatients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine | Drug | Group A (single shot,n=20) |
| continous ESPBPatients 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. | Drug | Group B (continous infusion,n=20) |
Primary outcome
Duration of postoperative Analgesia:
Time frame: post-operative period(24 hours)
"the time interval between extubation and the first request to postoperative analgesia
2 secondary outcomes
Duration of sensory block
Time frame: 24 hours
Visual analogue scale from 1 to 10,while 10 is the worst pain at rest and movement
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 29885165Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
- Background: PubMed 8017600Schug 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.
- Background: PubMed 29288788Choi 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.
- Background: PubMed 19602964Popping 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.
- Background: PubMed 22762468Farag 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing single shot ESBP with dexmedtomidine and continous ESPB in people with Stone, Kidney, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative Analgesia: (time frame: post-operative period(24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650737, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.