Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759963
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2021-01-23
Brief Title:
Impact of Epidural Anesthesia on Low Back Function
Sponsor:
South Valley University
Organization:
South Valley University
Study Overview
Official Title:
Impact of Obstetric Epidural Anesthesia on Mechanical Function of Low Back
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Back pain is a common complication after the use of epidural anesthesia in obstetric and non-obstetric surgeries and occurs in 30-45 of cases Brown 2005 Certain psychological problems such as depression or unhappiness due to loss of employment may prolong the episode of low back pain Miller 2012 According to Egyptian Institution of Health Metrics and Evaluation IHME Low Back Pain is the first cause of disability in Egypt from 2007 to 2017
So this study will investigate if midline approach of obstetric epidural anaesthesia will be a relative risk for subacute low back mechanical functions as a new way to examine if this type of anaesthesia is involved in the presence of subacute negative effects on the mechanical function of low back or not to resolve the controversy
So this study will investigate if midline approach of obstetric epidural anaesthesia will be a relative risk for subacute low back mechanical functions as a new way to examine if this type of anaesthesia is involved in the presence of subacute negative effects on the mechanical function of low back or not to resolve the controversy
Detailed Description:
The lumbar or lower back region is made up of five vertebrae L1-L5 sometimes including the sacrum Stability of the spine is provided by the ligaments and muscles of the back and abdomen Floyd and Thompson 2008
The primary biomechanical function of the spine is to provide structural support to allow the body to move freely and to protect the spinal cord and nerves Muscles balance external loads to the spine which supports the load and allows for the motion through its multilevel joint arrangement Dreischarf et al 2016
Low back pain LBP is a common minor yet unpleasant complication after epidural anesthesia Different mechanisms are suggested such as needle trauma and myotoxicity of local anesthetic Louizos et al 2005 and incidence of backache after epidural anaesthesia might be expected to be higher than that after spinal anaesthesia Brown and Elman 1961
In most episodes of low back pain a specific underlying cause is not identified or even looked for with the pain believed to be due to mechanical problems such as muscle or joint strain Casazza 2012 Most cases are idiopathic but usually attributable to muscle strain or ligament injury found in 65 to 70 of patients with mechanical chronic back pain Cohen et al 2008 while totally mechanical low back pain is reported as the cause in about 80 to 95 of patients with low back pain Cohen et al 2008 Dixit 2017
Caesarean section is when a baby is born through an incision in the mothers abdomen and uterine wall This requires effective anaesthesia which can be regional epidural or spinal or a general anaesthetic With regional epidural anaesthesia the anaesthetic is infused into the space around the mothers spinal column whilst with regional spinal anaesthesia the drug is injected as a single dose into the mothers spinal column With the two types of regional anaesthesia the mother is awake for the birth but numbed from the waist down while with general anaesthesia the mother is unconscious for the birth with the anaesthetic affecting her whole body Afolabi and Lesi 2012
The epidural needle can be placed using the midline or paramedian approach In both cases lidocaine 1 is infiltrated in the epidural needle insertion area
In the midline approach technique the needle is placed in the midline between 2 spine processes In the paramedian approach technique the needle is inserted 1 cm lateral and 1 cm caudal to the lower border of the upper spinous process
The epidural needle in the medline approach is advanced through ligaments supraspinous ligament interspinous ligament ligamentum flavum and into the target epidural space Each ligament has different density and texture which affects the feel of the needle and the resistance to insertion Vaughan et al 2013
Some explanations for Low Back Dysfunction after Epidural Anaesthesia
The incidence of back pain after epidural anesthesia is over 20 Rose 2012 Saghafinia et al 2009 Muslu et al 2009 It occurs rarely after spinal anesthesia Schwabe and Hopf 2001 This indicates that back pain may be associated with local trauma and nerve injury caused by the epidural needle leading to aseptic periosteitis tendonitis ligamentous inflammation andor osteochondritis which result in lumbar pain Kalso 2013
Excessive elongation of spinal ligaments can cause micro-trauma of the ligament fibers and tears or ruptures occur Also the interspinous ligaments are the first structures damaged excessive stretching when the spine is hyperflexed Adams et al 1998
Degeneration and excessive stress on the thoracolumbar fascia may also cause micro-trauma and resulting in tears Thoracolumbar fascia may become damaged by over-stretching or excessive stress potentially eliciting pain Bogduk 1983
Other contributing factors include needle trauma surgical positioning injection of saline or local anesthetic into the interspinous ligaments and development of a supraspinous hematoma Covet et al 1967 Crawford 1972
Excessive stretching of ligaments after relaxation of paraspinal muscles and localized trauma to the intervertebral disc has also been implicated in causing back pain Agarwal and Kishore 2009
Visual analogue scale VAS
The visual analogue scale is a validated subjective measure for acute and chronic pain Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain Delgado et al 2018
Pressure algometry
Pressure algometry has been described as a semi-objective method or subjective measure and Pain Pressure Threshold PPT is a quantitative sensory test of tissue sensitivity and it is defined as the minimal amount of pressure that produces pain measured via a pressure algometer Ylinen 2007
Inclinometers
An inclinometer or tilt meter is an instrument for measuring angles of slope or tilt elevation or depression of an object or body segment with respect to gravity Nielsen et al 2011
Oswestry Disability Index
The Oswestry Disability Index ODI is a valid reliable and responsive condition-specific assessment tool that is suited for use in clinical practice It is easy to administer and score objectifies clients complaints and monitors effects of therapy Vianin 2008
Isokinetic dynamometry
The isokinetic dynamometer is a gold standard instrument for measuring muscle strength and is safe valid and reliable based on the use of kinetic parameters that also include the angular measurement of a corporeal segment throughout the range of motion Gonosova et al 2018 Habets et al 2018 Roth et al 2017 Guilhem et al 2014
Ultrasound Elastography
Ultrasound elastography EUS is a recently developed ultrasound-based method which allows the qualitative visual or quantitative measurements of the mechanical properties of tissue Hall 2003 Garra 2007 Garra 2011
Myoton Pro Device
A MyotonPRO Myoton AS Estonia is a portable hand-held myotonometer that can assess muscle tone and soft tissue stiffness According to prior research the MyotonPRO is a reliable quantitative measurement for assessing the mechanical properties of muscles Pruyn et al 2016
The MyotonPRO can differentiate the viscoelastic properties of a trigger point from a non-trigger point Our findings support the reliability of this myotonometer This affordable and portable tool can be used to objectively measure viscoelastic properties of trigger points Roch et al 2020
The primary biomechanical function of the spine is to provide structural support to allow the body to move freely and to protect the spinal cord and nerves Muscles balance external loads to the spine which supports the load and allows for the motion through its multilevel joint arrangement Dreischarf et al 2016
Low back pain LBP is a common minor yet unpleasant complication after epidural anesthesia Different mechanisms are suggested such as needle trauma and myotoxicity of local anesthetic Louizos et al 2005 and incidence of backache after epidural anaesthesia might be expected to be higher than that after spinal anaesthesia Brown and Elman 1961
In most episodes of low back pain a specific underlying cause is not identified or even looked for with the pain believed to be due to mechanical problems such as muscle or joint strain Casazza 2012 Most cases are idiopathic but usually attributable to muscle strain or ligament injury found in 65 to 70 of patients with mechanical chronic back pain Cohen et al 2008 while totally mechanical low back pain is reported as the cause in about 80 to 95 of patients with low back pain Cohen et al 2008 Dixit 2017
Caesarean section is when a baby is born through an incision in the mothers abdomen and uterine wall This requires effective anaesthesia which can be regional epidural or spinal or a general anaesthetic With regional epidural anaesthesia the anaesthetic is infused into the space around the mothers spinal column whilst with regional spinal anaesthesia the drug is injected as a single dose into the mothers spinal column With the two types of regional anaesthesia the mother is awake for the birth but numbed from the waist down while with general anaesthesia the mother is unconscious for the birth with the anaesthetic affecting her whole body Afolabi and Lesi 2012
The epidural needle can be placed using the midline or paramedian approach In both cases lidocaine 1 is infiltrated in the epidural needle insertion area
In the midline approach technique the needle is placed in the midline between 2 spine processes In the paramedian approach technique the needle is inserted 1 cm lateral and 1 cm caudal to the lower border of the upper spinous process
The epidural needle in the medline approach is advanced through ligaments supraspinous ligament interspinous ligament ligamentum flavum and into the target epidural space Each ligament has different density and texture which affects the feel of the needle and the resistance to insertion Vaughan et al 2013
Some explanations for Low Back Dysfunction after Epidural Anaesthesia
The incidence of back pain after epidural anesthesia is over 20 Rose 2012 Saghafinia et al 2009 Muslu et al 2009 It occurs rarely after spinal anesthesia Schwabe and Hopf 2001 This indicates that back pain may be associated with local trauma and nerve injury caused by the epidural needle leading to aseptic periosteitis tendonitis ligamentous inflammation andor osteochondritis which result in lumbar pain Kalso 2013
Excessive elongation of spinal ligaments can cause micro-trauma of the ligament fibers and tears or ruptures occur Also the interspinous ligaments are the first structures damaged excessive stretching when the spine is hyperflexed Adams et al 1998
Degeneration and excessive stress on the thoracolumbar fascia may also cause micro-trauma and resulting in tears Thoracolumbar fascia may become damaged by over-stretching or excessive stress potentially eliciting pain Bogduk 1983
Other contributing factors include needle trauma surgical positioning injection of saline or local anesthetic into the interspinous ligaments and development of a supraspinous hematoma Covet et al 1967 Crawford 1972
Excessive stretching of ligaments after relaxation of paraspinal muscles and localized trauma to the intervertebral disc has also been implicated in causing back pain Agarwal and Kishore 2009
Visual analogue scale VAS
The visual analogue scale is a validated subjective measure for acute and chronic pain Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain Delgado et al 2018
Pressure algometry
Pressure algometry has been described as a semi-objective method or subjective measure and Pain Pressure Threshold PPT is a quantitative sensory test of tissue sensitivity and it is defined as the minimal amount of pressure that produces pain measured via a pressure algometer Ylinen 2007
Inclinometers
An inclinometer or tilt meter is an instrument for measuring angles of slope or tilt elevation or depression of an object or body segment with respect to gravity Nielsen et al 2011
Oswestry Disability Index
The Oswestry Disability Index ODI is a valid reliable and responsive condition-specific assessment tool that is suited for use in clinical practice It is easy to administer and score objectifies clients complaints and monitors effects of therapy Vianin 2008
Isokinetic dynamometry
The isokinetic dynamometer is a gold standard instrument for measuring muscle strength and is safe valid and reliable based on the use of kinetic parameters that also include the angular measurement of a corporeal segment throughout the range of motion Gonosova et al 2018 Habets et al 2018 Roth et al 2017 Guilhem et al 2014
Ultrasound Elastography
Ultrasound elastography EUS is a recently developed ultrasound-based method which allows the qualitative visual or quantitative measurements of the mechanical properties of tissue Hall 2003 Garra 2007 Garra 2011
Myoton Pro Device
A MyotonPRO Myoton AS Estonia is a portable hand-held myotonometer that can assess muscle tone and soft tissue stiffness According to prior research the MyotonPRO is a reliable quantitative measurement for assessing the mechanical properties of muscles Pruyn et al 2016
The MyotonPRO can differentiate the viscoelastic properties of a trigger point from a non-trigger point Our findings support the reliability of this myotonometer This affordable and portable tool can be used to objectively measure viscoelastic properties of trigger points Roch et al 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None