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Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.

Primary Purpose

Abdominal Cancer

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
quadratus lumborum
transversus abdominis plane
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients included in the study, aged 20-60 years,
  • with ASA Physical Status Class I and II,
  • scheduled for abdominal cancer surgery under general anesthesia

Exclusion Criteria:

  • infection at injection site,
  • allergy to local anesthetics,
  • coagulation disorders,
  • physical or mental diseases which could interfere with the evaluation of pain scores
  • kidney failure or liver failure.

Sites / Locations

  • Nevert Adel Abdel GhaffarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group quadratus lumborum

Group transversus abdominis plane

Arm Description

the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied

the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side

Outcomes

Primary Outcome Measures

The total dose of morphine
amount of morphine in mg

Secondary Outcome Measures

visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain

Full Information

First Posted
September 6, 2022
Last Updated
September 6, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05533424
Brief Title
Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.
Official Title
Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura 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
Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain. The aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and Transversus abdominis plane blocks for pain management after abdominal cancer surgery.
Detailed Description
Postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. Therefore, it is very important for perioperative patients to have a safe and effective pain management model. Although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. Recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes. As effective constituents of multimode analgesia, quadratus lumborum (QL) block and transversus abdominis plane (TAP) block are mainly used for postoperative analgesia in abdominal surgery. Aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group quadratus lumborum
Arm Type
Active Comparator
Arm Description
the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied
Arm Title
Group transversus abdominis plane
Arm Type
Active Comparator
Arm Description
the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side
Intervention Type
Other
Intervention Name(s)
quadratus lumborum
Intervention Description
the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied
Intervention Type
Other
Intervention Name(s)
transversus abdominis plane
Intervention Description
the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side
Primary Outcome Measure Information:
Title
The total dose of morphine
Description
amount of morphine in mg
Time Frame
in the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively at 30 min and 2, 4, 6, 12, and 24 hours
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively 2 hours
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively at 4 hours
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively at 6 hours
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively at 12 hours
Title
visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
postoperatively at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients included in the study, aged 20-60 years, with ASA Physical Status Class I and II, scheduled for abdominal cancer surgery under general anesthesia Exclusion Criteria: infection at injection site, allergy to local anesthetics, coagulation disorders, physical or mental diseases which could interfere with the evaluation of pain scores kidney failure or liver failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yahya m wahba, assist professor
Phone
01211313554
Email
yahyawahba@ymail.com
First Name & Middle Initial & Last Name or Official Title & Degree
adel abdel ghaffar
Phone
01210101001
Email
adelghaffar49@gmail.com
Facility Information:
Facility Name
Nevert Adel Abdel Ghaffar
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nevert A Abdel Ghaffar, MD
Phone
01223947977
Email
nevertadel@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Yahya M Wahba, MD
Phone
01211313554
Email
yahyawahba@ymail.com
First Name & Middle Initial & Last Name & Degree
nevert a abdel ghaffar, assist prof
First Name & Middle Initial & Last Name & Degree
ghada f amer, assist prof

12. IPD Sharing Statement

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Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.

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