- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05860309
Preoperative Versus Postoperative Quadratous Lunborum Block in Nephrectomy
Preoperative Versus Postoperative Ultrasound Guided Quadratous Lunborum Block for Postoperative Analgesia Following Open Nephrectomy, Acomparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the immediate postoperative period, nerve blocks are considered a type of multimodal analgesia and have recently been proposed as analgesic options for patients undergoing open nephrectomy .
Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. The main barrier to early postoperative ambulation is postoperative pain, which also lengthens hospital stays and raises the risk of respiratory problems and venous thromboembolism. Therefore, strict perioperative pain management can have both immediate and long-term advantages .
QLB provides early and rapid pain relief and allows early ambulation in certain patient populations. Multiple case studies also confirmed the QLB to be a rescue block after different surgical procedures. Complications associated with the performance of abdominal wall blocks are fortunately very rare. However, studies on the effect of anterior QLB on postoperative opioid consumption are scarce .
Regional anesthesia is quickly moving toward using ultrasound guidance as the gold standard. The use of ultrasound has significant advantages over traditional treatments such as nerve stimulation and loss of resistance. The improved safety and efficacy that ultrasound brings to regional anaesthesia will help promote its use and realise the benefits that regional anaesthesia has over general anaesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decreased postoperative complications and an improved postoperative course .
The aim of the present study is to compare the effectiveness of ultrasound-guided preoperative to postoperative QLB on the postoperative pain scores after Radical nephrectomy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11591
- Ainshams hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
o Patients aged between 18 - 60 years old.
- Both sexes.
- Physical Status: ASA I and II.
Exclusion Criteria:
o Refusal of procedure or participation in the study .
- Physical status: ASA III or above .
- Infection at site of injection.
- Psychiatric illness .
- CNS Diseases like epilepsy, stroke …etc.
- History or evidence of coagulopathy .
- Allergies to drug used (Bupivacaine 0.5%).
- Patients who suffered from allergy to local anesthetics .
- Difficult visualization of the anatomy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: preoperative quadratous lumborum block
patients weill recieve preoperative ultrasound guided quadratous lumborum block at lateral position before start of surgery after induction of general anesthesia
|
The patient will be placed in the lateral position, after sterilization.. QLB will be done using ultrasound, The probe will be positioned superior to the iliac crest, in the transverse orientation, at the posterior axillary line.
The Shamrock sign will be identified at the L4 level, and the insulated nerve block needle will be advanced from posterior to anterior, through the QL muscle, until the needle tip is visualized in the interfascial plane between the QL muscle and psoas muscle.
As the correct needle placement is confirmed with 2-3 mL of saline, 20 mL of 0.25% bupivacaine will be injected ensuring that the psoas muscle will be pushed deeply.
Other Names:
|
|
Active Comparator: postoperative quadratous lumborum block
patients weill recieve postoperative ultrasound guided quadratous lumborum block at lateral position at the end of surgery before recovery from general anesthesua
|
The patient will be placed in the lateral position, after sterilization.. QLB will be done using ultrasound, The probe will be positioned superior to the iliac crest, in the transverse orientation, at the posterior axillary line.
The Shamrock sign will be identified at the L4 level, and the insulated nerve block needle will be advanced from posterior to anterior, through the QL muscle, until the needle tip is visualized in the interfascial plane between the QL muscle and psoas muscle.
As the correct needle placement is confirmed with 2-3 mL of saline, 20 mL of 0.25% bupivacaine will be injected ensuring that the psoas muscle will be pushed deeply.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The time to first postoperative rescue analgesia.
Time Frame: postoperative 24 hours
|
the first time patient ask for analgesia
|
postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total consumption of opioid in first 24 hours
Time Frame: first 24 hours postoperatively
|
amount of narcotic needed by patient in first 24 hours after nephrectomy
|
first 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: sanaa F wasfy, Ain Shams University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MS 183/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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