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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04402411
Other study ID # 201617049.3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date October 5, 2020

Study information

Verified date October 2020
Source National Cancer Institute, Egypt
Contact Ahmed M Mohammed, MSc
Phone +20 122 431 8828
Email mans.cerano@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date October 5, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.
Drug:
Intravenous opioid
Patients will receive morphine 0.1 mg/kg

Locations

Country Name City State
Egypt National Cancer Institute - Egypt Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 24 hours
Secondary 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. 24 hours
Secondary 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
24 hours
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