Percutaneous NephrolithotomyNCT05725083
Lower Thoracic Epidural vs Erector Spinae Block for PNL
A study testing Lower thoracic epidural and Erector spinae plane block in people with Percutaneous Nephrolithotomy, run by Assiut University.
Trial summary
compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower Thoracic Epidural and Erector spinae plane block are effective in providing post-operative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Lower thoracic epidural and Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2024to Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective Percutaneous Nephrolithotomy.
Who cannot join
- Contraindication to local anesthesia :
- Allergy to local anaesthetics , Infection at the site of injection , Coagulopathy
- Chronic pain syndromes
- Prolonged opioid medication
- Patients who received any analgesic 24 h before surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lower Thoracic Epidural Versus Erector Spinae Block for Postoperative Analgesia for Percutaneous Nephrolithotomy
compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower Thoracic Epidural and Erector spinae plane block are effective in providing post-operative analgesia.
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with multiple or complex kidney or upper urinary tract stones, which necessitates the meticulous multi-modality analgesia due to mild to moderate pain originated from renal capsule dilation or nephrostomy-tube-related stress during the first 24 h after operation.
The main sources of the acute pain after PCNL are visceral pain originating from the kidneys and ureters, and somatic pain from the site incision. Renal pain is conducted through T10-L1 spinal nerves while ureter pain is conducted through T10-L2. Moreover, cutaneous innervation of the site of the incision is predominantly supplied by T10-T11 (T8-T12) because the incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space, or in the subcostal area Blockade of both somatic and visceral nerves that innervate skin, muscle, kidneys, and ureters is required for the achievement of adequate analgesia after PCNL. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as Lower Thoracic Epidural , Thoracic paravertebral block, Transversus abdominis block, Erector spinae block, and peri-tubal local anaesthetic infiltration .
PCNL surgery also has an increased risk for postoperative pulmonary complications because the procedure is performed near the diaphragm, especially, when approached through the upper pole of the kidney which increases the possibility of pleural and lung injuries. with poor control of the postoperative pain, this can result in decreased inspiratory and vital capacities and increase the incidence of lung atelectasis and postoperative hypoxemia. Multimodal analgesia techniques are utilized broadly to manage postoperative pain. The concept of multimodal analgesia implies not only providing analgesic drugs, but also performing nerve blocks with local anaesthetics.
Since Forrero et al. first described the Erector Spinae Plane Block (ESPB), the indications and clinical use of the block for different surgical interventions have been growing . Although, ESPB is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may derive from spread to the paravertebral and epidural space. Regional anesthesia may reduce the rate of chronic pain after surgery . Thoracic epidural blockade (TEB) using local anesthetic agents has been widely regarded as the gold standard for analgesia and reduction of associated complications following surgery.
Epidural analgesia was first accomplished by blockage with local anesthetics, and bupivacaine has been called the local anesthetic of choice for epidural infusion.. Epidural local anesthetics have been administered by continuous infusion in an attempt to minimize side effects , Nevertheless, hypotension as well as motor block , numbness , nausea and urinary retention have occurred.
Good analgesia from an epidural block can result in relieving postoperative pain , early extubation, better ventilatory mechanics and gas exchange and reduced rates of lung collapse, pneumonia and pain . However, the technique requires highly trained medical staff not only for insertion and removal of the epidural catheter but also for the management of the continuous infusion of pain medication. The risks associated with insertion of the epidural include accidental dural puncture, inadvertent high block, local anesthetic toxicity and total spinal anesthesia (inadvertent spinal injection of an epidural dose of local anesthetic), nerve injury, epidural hematoma and abscess are rare but serious complications.
Epidural is not a suitable technique for all patients and is contraindicated in patients with local infection, previous spinal surgery, disorders of blood clotting and in those taking anti-coagulant and anti-platelet therapy .
Thus, in the current study the investigators aim to compare the post-operative analgesic effect of Lower Thoracic Epidural with that of ESPB after Percutaneous Nephrolithotomy.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Lower thoracic epidural, Erector spinae plane block
- Keywords
- Lower thoracic epidural, Erector spinae block, Postoperative analgesia for PCNL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower thoracic epiduralProcedure or surgery
before induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs.
Erector spinae plane blockProcedure or surgery
before induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs.
| Study group | Role | What they receive |
|---|---|---|
| Lower thoracic epiduarl | Experimental | before induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs. Receives: Procedure: Lower thoracic epidural |
| Erector spinae block | Experimental | before induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total opioid used
Measured: 48 hours postoperatively
Secondary outcomes (9)
First analgesic request
When the patient first time need analgesia
Measured: 48 hours postoperatively
Pain scores
Numerical rating scale
Measured: 48 hours postoperatively
Analgesic drug consumption other than Nalbuphine
Another drug needed and it's consumption
Measured: 48 hours postoperatively
Ambulation Time
The time the patient first ambulated following the surgical procedure
Measured: 48 hours postoperatively
Patient satisfaction with anathesia
If the patient feels pain using Visual Analogue Scale
Measured: 48 hours postoperativelyi
Heart rate in beats per minute
Heart rate be stable during operation
Measured: Intraoperatively
Mean arterial pressure in mmHg
Be stable during operation
Measured: Intraoperatively
Incidence of postoperative nausea and vomiting
If the patient feels vomiting and nausea and when
Measured: 48 hours
Block related complication
If there is any complications as local anesthetic toxicity , pneumothorax and vascular puncture during block procedure
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start11 Jan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keroles Heshmat Ghaly Seif, Assiut University
- Investigators
- Mohamed Mohamed Abd EL Latif, Professor, Study chair, Assuit University HospitalAmr Mohamed Ahmed Thabet, Lecturer, Study director, Assuit University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725083
- Sponsor's protocol ID
- Epidural vs ESPB in PCNL
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Thoracic Epidural Versus Erector Spinae Block for Postoperative Analgesia for Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05725083
- Acronym / sponsor ID
- Epidural vs ESPB in PCNL
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Lower thoracic epidural, Erector spinae block, Postoperative analgesia for PCNL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2023 (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.
compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower Thoracic Epidural and Erector spinae plane block are effective in providing post-operative analgesia.
Detailed description
Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with multiple or complex kidney or upper urinary tract stones, which necessitates the meticulous multi-modality analgesia due to mild to moderate pain originated from renal capsule dilation or nephrostomy-tube-related stress during the first 24 h after operation.
The main sources of the acute pain after PCNL are visceral pain originating from the kidneys and ureters, and somatic pain from the site incision. Renal pain is conducted through T10-L1 spinal nerves while ureter pain is conducted through T10-L2. Moreover, cutaneous innervation of the site of the incision is predominantly supplied by T10-T11 (T8-T12) because the incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space, or in the subcostal area Blockade of both somatic and visceral nerves that innervate skin, muscle, kidneys, and ureters is required for the achievement of adequate analgesia after PCNL. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as Lower Thoracic Epidural , Thoracic paravertebral block, Transversus abdominis block, Erector spinae block, and peri-tubal local anaesthetic infiltration .
PCNL surgery also has an increased risk for postoperative pulmonary complications because the procedure is performed near the diaphragm, especially, when approached through the upper pole of the kidney which increases the possibility of pleural and lung injuries. with poor control of the postoperative pain, this can result in decreased inspiratory and vital capacities and increase the incidence of lung atelectasis and postoperative hypoxemia. Multimodal analgesia techniques are utilized broadly to manage postoperative pain. The concept of multimodal analgesia implies not only providing analgesic drugs, but also performing nerve blocks with local anaesthetics.
Since Forrero et al. first described the Erector Spinae Plane Block (ESPB), the indications and clinical use of the block for different surgical interventions have been growing . Although, ESPB is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may derive from spread to the paravertebral and epidural space. Regional anesthesia may reduce the rate of chronic pain after surgery . Thoracic epidural blockade (TEB) using local anesthetic agents has been widely regarded as the gold standard for analgesia and reduction of associated complications following surgery.
Epidural analgesia was first accomplished by blockage with local anesthetics, and bupivacaine has been called the local anesthetic of choice for epidural infusion.. Epidural local anesthetics have been administered by continuous infusion in an attempt to minimize side effects , Nevertheless, hypotension as well as motor block , numbness , nausea and urinary retention have occurred.
Good analgesia from an epidural block can result in relieving postoperative pain , early extubation, better ventilatory mechanics and gas exchange and reduced rates of lung collapse, pneumonia and pain . However, the technique requires highly trained medical staff not only for insertion and removal of the epidural catheter but also for the management of the continuous infusion of pain medication. The risks associated with insertion of the epidural include accidental dural puncture, inadvertent high block, local anesthetic toxicity and total spinal anesthesia (inadvertent spinal injection of an epidural dose of local anesthetic), nerve injury, epidural hematoma and abscess are rare but serious complications.
Epidural is not a suitable technique for all patients and is contraindicated in patients with local infection, previous spinal surgery, disorders of blood clotting and in those taking anti-coagulant and anti-platelet therapy .
Thus, in the current study the investigators aim to compare the post-operative analgesic effect of Lower Thoracic Epidural with that of ESPB after Percutaneous Nephrolithotomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower thoracic epiduarl | Experimental | Procedure: Lower thoracic epiduralbefore induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs. |
| Erector spinae block | Experimental | Procedure: Erector spinae plane blockbefore induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective Percutaneous Nephrolithotomy.
Key exclusion criteria (5 listed)
- Contraindication to local anesthesia :
- Allergy to local anaesthetics , Infection at the site of injection , Coagulopathy
- Chronic pain syndromes
- Prolonged opioid medication
- Patients who received any analgesic 24 h before surgery.
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 |
|---|---|---|
| Lower thoracic epiduralbefore induction of anesthesia,first the investigators identify the correct targeted thoracic level. All epidural block will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheter will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection. Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15ml/h .for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1 mg bolus , 10 min lockout period . The catheter will be removed under complete aseptic precautions after 48 hrs. | Procedure or surgery | Lower thoracic epiduarl |
| Erector spinae plane blockbefore induction of anasthesia ,highfrequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle.confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.Then the catheter placement 5cm into the space under the erector spinae muscle and suitable test dose will be administered . Bupivacaine 0.25% of 7.5-12 ml volume will be given bolus through the catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h , for breakthrough pain patient controlled analgesia (PCA) using nalbuphine 1mg bolus,10 min lockout period.The catheter will be removed under complete aseptic precautions after 48 hrs. | Procedure or surgery | Erector spinae block |
Primary outcome
Total opioid consumption
Time frame: 48 hours postoperatively
Total opioid used
9 secondary outcomes
First analgesic request
Time frame: 48 hours postoperatively
Pain scores
Time frame: 48 hours postoperatively
Analgesic drug consumption other than Nalbuphine
Time frame: 48 hours postoperatively
Ambulation Time
Time frame: 48 hours postoperatively
Patient satisfaction with anathesia
Time frame: 48 hours postoperativelyi
Heart rate in beats per minute
Time frame: Intraoperatively
Mean arterial pressure in mmHg
Time frame: Intraoperatively
Incidence of postoperative nausea and vomiting
Time frame: 48 hours
Block related complication
Time frame: 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Paravertebral block for surgical anesthesia of percutaneous nephrolithotomyLink provided by the sponsor.
- abdominal wall blocksLink provided by the sponsor.
- Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patientLink provided by the sponsor.
- Thoracic paravertebral block versus epidural anesthesia combined with moderate sedation for percutaneous nephrolithotomyLink provided by the sponsor.
- Percutaneous nephrolithotomy under a multimodal analgesia regime.Link provided by the sponsor.
- Application of TAP block in laparoscopic urologic surgery: Current status and future directions.Link provided by the sponsor.
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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.
Mohamed Mohamed Abd EL Latif, Professor study chair
Assuit University Hospital
Amr Mohamed Ahmed Thabet, Lecturer study director
Assuit University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lower thoracic epidural and Erector spinae plane block in people with Percutaneous Nephrolithotomy, run by Assiut 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 3 inclusion and 5 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 11 Jan 2024. 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?
Contact keroles Heshmat Ghaly, MBBS (01271655519, kero.heshoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.