Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Primary Purpose
Analgesia
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Posterior TAP block
ESPB
Sponsored by
About this trial
This is an interventional prevention trial for Analgesia focused on measuring Percutaneous nephrolithotomy, Erector spinae plane block, Transversus abdominis plane block
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for PCNL under general anesthesia
- ASA status I-II
Exclusion Criteria:
- Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
- Patient who has difficulty understanding the study protocol or patient refusal.
- Chronic respiratory disease patients.
- Diabetic patients.
- Body mass index (BMI) > 30 Kg/m2
- Routine corticosteroids, pain medication, or anticonvulsant.
- Psychiatric diseases.
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Posterior TAP block
ESPB
Arm Description
Outcomes
Primary Outcome Measures
The time to first call rescue analgesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448495
Brief Title
Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Official Title
Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy. A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
To compare the analgesic efficacy of posterior TAP block versus ESPB after PCNL surgery. The hypothesis is that posterior TAP block, as a part of multimodal analgesia, will reduce pain and opioid consumption like ESPB
Detailed Description
Percutaneous nephrolithotomy (PCNL) is currently the gold standard for treatment of patients with large and complex renal calculi because it is less invasive than open surgery. The sources of acute pain after PCNL are visceral pain originating from kidneys and ureters, and somatic pain from the site incision. PCNL is usually done in 10th to 11th intercostal space or in the subcostal area. 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 thoracic paravertebral block, transversus abdominis plane (TAP) block, erector spinae plane block (ESPB).
ESPB is an interfascial block which can provide wide sensory blockade from T2-4 to L1-2 that was first described in 2016. ESPB can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle with nearly one dermatome for each 3.4 ml of the injected volume. This allows ESPB to provide both visceral and somatic analgesia. TAP block is a regional injection of a local anesthetic agent between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1). Various technical modifications in TAP block have been described including lateral, posterior, subcostal, and continuous catheter techniques. The posterior approach should be the preferred technique in clinical practice as it provides longer somatic and visceral analgesia that are not offered with the lateral approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Percutaneous nephrolithotomy, Erector spinae plane block, Transversus abdominis plane block
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior TAP block
Arm Type
Experimental
Arm Title
ESPB
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Posterior TAP block
Other Intervention Name(s)
Posterior transversus abdominis plane block
Intervention Description
Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine [0.5 mcg\kg] + 2ml dexamethasone [0.1mg\kg)] will be injected at the plane between internal oblique and transversus abdominis near the aponeurosis at the posterior axillary line.
Intervention Type
Other
Intervention Name(s)
ESPB
Other Intervention Name(s)
Erector spinae plane block
Intervention Description
Using high-frequency linear ultrasound probe, a total volume of 24 ml (20 ml isobaric bupivacaine 0.5% + 2 ml dexmedetomidine [0.5 mcg\kg] + 2ml dexamethasone [0.1mg\kg)] will be injected at T9 erector spinae plane
Primary Outcome Measure Information:
Title
The time to first call rescue analgesia
Time Frame
From end of surgery till 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for PCNL under general anesthesia
ASA status I-II
Exclusion Criteria:
Contraindications to regional block (coagulopathy, infection at the needle insertion site or known allergy to amide local anesthetics)
Patient who has difficulty understanding the study protocol or patient refusal.
Chronic respiratory disease patients.
Diabetic patients.
Body mass index (BMI) > 30 Kg/m2
Routine corticosteroids, pain medication, or anticonvulsant.
Psychiatric diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Nabil, M.D.
Phone
+201003633992
Email
fatmanabil2012@aun.edu.eg
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma Nabil, M.D.
Phone
+201003633992
Email
fatmanabil2012@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Posterior Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as a Part of Multimodal Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
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