Condition or disease | Intervention/treatment | Phase |
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Quadratus Lumborum Block | Procedure: Quadratus Lumborum block | Early Phase 1 |
A variant of the ultrasound-guided transversus abdominis plane (TAP) block was first described in an abstract, in which local anesthetic injection occurs at the point where the internal oblique and transversus abdominis muscles taper off and adjoin the lateral border of quadratus lumborum (QL) muscle.
Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery.
However, there is large disagreement regarding the best approach for administering the block because of unclear mechanisms responsible for the effects and complicated nomenclature system. Nephrectomy for patients with renal cell carcinoma (RCC) was first described in 1969. Surgical treatment varies with the pathology. Simple nephrectomy is the preferred option for those with non-neoplastic disease (e.g. trauma, non-functioning kidney with chronic infection) with radical nephrectomy being preferred in those with neoplastic disease. Radical nephrectomy implies resection of the whole of Gerota's fascia, including the perinephric fat, lymphatics, and the ipsilateral adrenal gland. Here the investigators are going to compare the Anterior (subcostal) approach to the Posterior approach to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Nephrectomy surgery.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | 1.1 English Title of Research Project: Comparing the Efficacy of Ultrasound Guided Quadratus Lumborum Block Anterior Subcostal Versus Posterior Approach in Managing Postoperative Pain in Patients Undergoing Nephrectomy Surger: A Prospective Randomized Controlled Double Blinded Study |
Estimated Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | July 1, 2021 |
Estimated Study Completion Date : | September 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Quadratus Lumborum Block anterior subcostal (QLa)
Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.125 bupivacaine.
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Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
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Active Comparator: Quadratus Lumborum Block posterior (QLp)
Patients in this group will receive Posterior Quadratus Lumborum block postoperative with 30 ml of 0.125 bupivacaine.
|
Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
|
Placebo Comparator: Quadratus Lumborum Block anterior subcostal control (QLca)
Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.9% normal saline.
|
Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
|
Placebo Comparator: Quadratus Lumborum Block posterior control (QLcp)
Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.9% normal saline.
|
Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
|
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sherif Bekhet | 00201155538773 | bekhetsherif89@gmail.com | |
Contact: Mohammed Mostafa | 00201001123062 | Mo7_fathy@yahoo.com |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||||
First Posted Date ICMJE | June 4, 2019 | ||||||||
Last Update Posted Date | March 3, 2020 | ||||||||
Estimated Study Start Date ICMJE | July 1, 2020 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
using the numeric rating scale to determine the effect of Quadratus Lumborum block in reducing the postoperative pain in patients undergoing nephrectomy surgery [ Time Frame: baseline ] to evaluate the efficacy of Quadratus Lumborum Block in the control of postoperative pain in patients undergoing Nephrectomy surgery, hemodynamics, any complications and patients' satisfaction.The Numeric rating scale (NRS) both resting and ambulatory which measures pain as felt by the patient every two hours for the first 24 hours then every six hours for the second day. the Numeric rating scale is a scale from 0 to 10 with '0' being lowest pain or no pain and '10' is the worst pain felt.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Anterior vs. Posterior Quadratus Lumborum Block in Nephrectomy Patients | ||||||||
Official Title ICMJE | 1.1 English Title of Research Project: Comparing the Efficacy of Ultrasound Guided Quadratus Lumborum Block Anterior Subcostal Versus Posterior Approach in Managing Postoperative Pain in Patients Undergoing Nephrectomy Surger: A Prospective Randomized Controlled Double Blinded Study | ||||||||
Brief Summary |
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Detailed Description |
A variant of the ultrasound-guided transversus abdominis plane (TAP) block was first described in an abstract, in which local anesthetic injection occurs at the point where the internal oblique and transversus abdominis muscles taper off and adjoin the lateral border of quadratus lumborum (QL) muscle. Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. However, there is large disagreement regarding the best approach for administering the block because of unclear mechanisms responsible for the effects and complicated nomenclature system. Nephrectomy for patients with renal cell carcinoma (RCC) was first described in 1969. Surgical treatment varies with the pathology. Simple nephrectomy is the preferred option for those with non-neoplastic disease (e.g. trauma, non-functioning kidney with chronic infection) with radical nephrectomy being preferred in those with neoplastic disease. Radical nephrectomy implies resection of the whole of Gerota's fascia, including the perinephric fat, lymphatics, and the ipsilateral adrenal gland. Here the investigators are going to compare the Anterior (subcostal) approach to the Posterior approach to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Nephrectomy surgery. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Early Phase 1 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Supportive Care |
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Condition ICMJE | Quadratus Lumborum Block | ||||||||
Intervention ICMJE | Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
120 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 1, 2021 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03973398 | ||||||||
Other Study ID Numbers ICMJE | QLB in Nephrectomy | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Sherif Mahmoud Mohammed Bekhet, Assiut University | ||||||||
Study Sponsor ICMJE | Sherif Mahmoud Mohammed Bekhet | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Assiut University | ||||||||
Verification Date | February 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |