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出境医 / 临床实验 / Anterior vs. Posterior Quadratus Lumborum Block in Nephrectomy Patients

Anterior vs. Posterior Quadratus Lumborum Block in Nephrectomy Patients

Study Description
Brief Summary:
  • Primary outcome: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block.
  • Secondary outcome: 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..

Condition or disease Intervention/treatment Phase
Quadratus Lumborum Block Procedure: Quadratus Lumborum block Early Phase 1

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.
Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain

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

Outcome Measures
Primary Outcome Measures :
  1. Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Numeric Rating Scale. [ Time Frame: baseline ]
    : to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by 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.

  2. Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire. [ Time Frame: baseline ]
    to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by the Revised American Pain Society Patient Outcome Questionnaire which is a set of questions answered by the patient to evaluate the patient's satisfaction and for quality improvement of pain management in hospitalized patients


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both sex
  • Age: 18-60 years.
  • ASA I and II
  • Elective surgery

Exclusion Criteria:

  • Patient's refusal.
  • Allergy to local anesthetics.
  • Peripheral neuropathy.
  • Bleeding diathesis.
  • Inflammation or infection over injection site.
  • Morbid obesity.
  • Patients on previous opioid therapy.
  • Psychiatric disorders.
  • Emergency surgery
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sherif Bekhet 00201155538773 bekhetsherif89@gmail.com
Contact: Mohammed Mostafa 00201001123062 Mo7_fathy@yahoo.com

Sponsors and Collaborators
Sherif Mahmoud Mohammed Bekhet
Tracking Information
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
 (submitted: June 2, 2019)
  • Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Numeric Rating Scale. [ Time Frame: baseline ]
    : to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by 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.
  • Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire. [ Time Frame: baseline ]
    to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by the Revised American Pain Society Patient Outcome Questionnaire which is a set of questions answered by the patient to evaluate the patient's satisfaction and for quality improvement of pain management in hospitalized patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
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.
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
  • Primary outcome: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block.
  • Secondary outcome: 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..
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.

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
Condition  ICMJE Quadratus Lumborum Block
Intervention  ICMJE Procedure: Quadratus Lumborum block
ultrasound guided Quadratus Lumborum block for postoperative pain
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Quadratus Lumborum block
  • 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.
    Intervention: Procedure: Quadratus Lumborum block
  • 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.
    Intervention: Procedure: Quadratus Lumborum block
  • 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.
    Intervention: Procedure: Quadratus Lumborum block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019)
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:

  • Both sex
  • Age: 18-60 years.
  • ASA I and II
  • Elective surgery

Exclusion Criteria:

  • Patient's refusal.
  • Allergy to local anesthetics.
  • Peripheral neuropathy.
  • Bleeding diathesis.
  • Inflammation or infection over injection site.
  • Morbid obesity.
  • Patients on previous opioid therapy.
  • Psychiatric disorders.
  • Emergency surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherif Bekhet 00201155538773 bekhetsherif89@gmail.com
Contact: Mohammed Mostafa 00201001123062 Mo7_fathy@yahoo.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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