Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries
Primary Purpose
Quadratus Lumborum Block, Transversus Abdominis Plane Block, Bladder Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quadratus lumborum block
Transversus abdominis plane block
Intravenous opioid
Sponsored by
About this trial
This is an interventional other trial for Quadratus Lumborum Block
Eligibility Criteria
Inclusion Criteria:
- Age of the patients between 20 to 80 years.
- ASA physical status II -III
- Elective bladder cancer operations.
Exclusion Criteria:
- Patient refusal
- Local infection at the site of injection
- Allergy to study medications
- Sepsis
- Anatomic abnormalities
- Systemic anticoagulation or coagulopathy
- Inability to comprehend or participate in pain scoring system
Sites / Locations
- National Cancer Institute - EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control Group
Quadratus lumborum
Transversus abdominis plane
Arm Description
Patients will receive general anesthesia with intravenous opioid
Patients will receive bilateral quadratus lumborum block
Patients will receive bilateral transversus abdominis plane block
Outcomes
Primary Outcome Measures
Time to first rescue dose of morphine
First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)
Secondary Outcome Measures
Total dose of postoperative morphine consumption
Postoperative analgesia was provided by 1 gm paracetamol IV every 8 hours as a routine analgesia and if VAS was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours.
Pain intensity by visual analogue scale (VAS)
Visual analogue scale (VAS) was recorded at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24 hours postoperative.
(0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain and 10: The worst imaginable pain) Minimum:0 and Maximum 10 The higher, the worst
Full Information
NCT ID
NCT04402411
First Posted
April 18, 2020
Last Updated
October 15, 2020
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04402411
Brief Title
Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries
Official Title
Comparison Between Quadratus Lumborum Block and Transversus Abdominis Plane Block in Bladder Cancer Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt
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
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures 4, 5.
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10
The aim of this study is to compare between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
Detailed Description
Somatic post-surgical pain is very distressing to patients which leads to important complications. Combined multimodal strategies involving nerve blocks, neuroaxial blocks, opiates, and non-steroidal anti-inflammatory drugs are necessary for optimal pain control.
Transversus abdominis plane (TAP) block can be used to provide effective analgesia during the postoperative period following a range of surgeries.
TAP block administers local anesthetics between the T6 to L1 spinal nerve roots to stop the nerve signal and to alleviate pain for abdominal procedures.
A number of systematic reviews have assessed TAP block as a postoperative analgesic compared to one or more specific procedures.
Anterior abdominal wall blocks, as transverse abdominal plexus block, have an important role for only somatic intraoperative and postoperative pain control.
The viscera are innervated by the vagal nerve (parasympathetic innervation) and by the splanchnic nerves (sympathetic innervation). The splanchnic nerves carry both visceral efferent and afferent nerve fibers. The sensory (or afferent) part of the splanchnic nerves reach the spinal column at certain spinal segments, It is possible to block central visceral pain conduction with thoracic paravertebral blockade or maybe even with the novel quadratus lumborum (QL) block.
The effect of the QL block is believed to result from a spread of LA from its lumbar deposition cranially into the thoracic paravertebral space (TPVS), since Carney et al found traces of contrast agent in the TPVS following application of this block. Hence, the QL block would seem to be able to alleviate both somatic and visceral pain.10 Quadratus lumborum block was first described by Blanco in 2007. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle. It has been used in abdominoplasties, caesarean sections and lower abdominal operations providing complete pain relief in the distribution area from Th6 to L1 dermatomes. It may be seen as a lumbar approach to the Thoracic Paravertebral Space. The block apparently produces distribution of the local anesthetic extending proximally and over both sides of the surface of the QL muscle, in between the anterior and intermediate layers of the thoracolumbar fascia.
Quadratus lumborum muscle inserts on the lower border of the last rib and by four small tendons into the apices of the transverse processes of the upper four lumbar vertebrae.
Running between its fascia and the muscle are the twelfth thoracic (subcostal), ilioinguinal, and iliohypogastric nerves, The block does not rely on the feeling of any pops or fascial clicks because depending of the angle of the needle several pops can be felt without reaching the target zone, which is lateral to the quadratus lumborum muscle. Actually, the block has never been intended to be conducted without the use of US guidance, and the block is thus a purely USG block.
Aim of study Comparison between quadratus lumborum block, transversus abdominis plane block regarding perioperative analgesia after bladder cancer surgeries by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Block, Transversus Abdominis Plane Block, Bladder Cancer, Postoperative Pain, Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients will receive general anesthesia with intravenous opioid
Arm Title
Quadratus lumborum
Arm Type
Experimental
Arm Description
Patients will receive bilateral quadratus lumborum block
Arm Title
Transversus abdominis plane
Arm Type
Experimental
Arm Description
Patients will receive bilateral transversus abdominis plane block
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Other Intervention Name(s)
Group B
Intervention Description
The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Other Intervention Name(s)
Group C
Intervention Description
The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed.
The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest.
The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles.
Intervention Type
Drug
Intervention Name(s)
Intravenous opioid
Other Intervention Name(s)
Group A
Intervention Description
Patients will receive morphine 0.1 mg/kg
Primary Outcome Measure Information:
Title
Time to first rescue dose of morphine
Description
First time at which morphine was given postoperatively (If Vsual analogue scale (VAS) was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total dose of postoperative morphine consumption
Description
Postoperative analgesia was provided by 1 gm paracetamol IV every 8 hours as a routine analgesia and if VAS was >4, 3 mg morphine IV was administered as a rescue analgesia for the first 24 hours.
Time Frame
24 hours
Title
Pain intensity by visual analogue scale (VAS)
Description
Visual analogue scale (VAS) was recorded at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24 hours postoperative.
(0: No pain, 1-3: Mild pain, 4-6: Moderate pain, 7-9: Severe pain and 10: The worst imaginable pain) Minimum:0 and Maximum 10 The higher, the worst
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of the patients between 20 to 80 years.
ASA physical status II -III
Elective bladder cancer operations.
Exclusion Criteria:
Patient refusal
Local infection at the site of injection
Allergy to study medications
Sepsis
Anatomic abnormalities
Systemic anticoagulation or coagulopathy
Inability to comprehend or participate in pain scoring system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Mohammed, MSc
Phone
+20 122 431 8828
Email
mans.cerano@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Mohammed, MSc
Organizational Affiliation
Assistant lecturer of Anesthesia, ICU, and Pain Relief
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute - Egypt
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atef Badran, PhD
Phone
0020101200155
Email
atef.badran@nci.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
I don't want to share
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Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries
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