- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402411
Quadratus Lumborum Block vs Transversus Abdominis Plane Block in Bladder Cancer Surgeries
Comparison Between Quadratus Lumborum Block and Transversus Abdominis Plane Block in Bladder Cancer Surgeries
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11796
- Recruiting
- National Cancer Institute - Egypt
-
Contact:
- Atef Badran, PhD
- Phone Number: 0020101200155
- Email: atef.badran@nci.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Patients will receive general anesthesia with intravenous opioid
|
Patients will receive morphine 0.1 mg/kg
Other Names:
|
|
Experimental: Quadratus lumborum
Patients will receive bilateral quadratus lumborum block
|
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.
Other Names:
|
|
Experimental: Transversus abdominis plane
Patients will receive bilateral transversus abdominis plane block
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first rescue dose of morphine
Time Frame: 24 hours
|
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)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total dose of postoperative morphine consumption
Time Frame: 24 hours
|
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.
|
24 hours
|
|
Pain intensity by visual analogue scale (VAS)
Time Frame: 24 hours
|
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 |
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed M Mohammed, MSc, Assistant lecturer of Anesthesia, ICU, and Pain Relief
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201617049.3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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