Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02821676
Status:
UNKNOWN
Last Update Posted:
2016-07-01
First Post:
2016-05-31
Brief Title:
PECISPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Randomized Controlled Comparison of PECISPB Versus Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
NOT_YET_RECRUITING
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:
Regional Anesthesia is a procedure in which numbing medication is injected around nerves that transmit pain from areas involved in a surgery The objective is to block the nerves so a patient does not feel pain after surgery Regional nerve blocks offer many advantages over traditional anesthetic techniques including faster recovery time fewer side effects and a dramatic reduction in post-surgical pain
The use of regional anesthesia in breast reconstructive surgery such as the latissimus dorsi flap has led to major improvements in patient care Today the most common regional anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block where numbing medication is injected around the nerves supplying the chest wall
While intercostal nerve blocks have been used successfully in breast surgery they do not provide a complete nerve block to the chest wall as there are some nerves that are unaccounted for in the block which can contribute to a patients pain after surgery
The mixed pectoral one serratus plane block PECISPB block is another regional nerve block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers a more complete pain blockade than the intercostal nerve block as it includes more nerves that supply the breast In addition to this the intercostal nerve block is a so-called blind-technique compared to the PECISPB block which is more accurately guided by ultrasound Blind techniques are associated with higher failure rates
Both the intercostal nerve block and the PECISPB nerve block have been used successfully at the Ottawa Hospital In this study the investigators propose a prospective double blinded randomized controlled head to head comparison of the PECISPB and intercostal nerve block to determine which block is associated with the best pain blockade and patient satisfaction in lattissimus dorsi flap surgery
The use of regional anesthesia in breast reconstructive surgery such as the latissimus dorsi flap has led to major improvements in patient care Today the most common regional anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block where numbing medication is injected around the nerves supplying the chest wall
While intercostal nerve blocks have been used successfully in breast surgery they do not provide a complete nerve block to the chest wall as there are some nerves that are unaccounted for in the block which can contribute to a patients pain after surgery
The mixed pectoral one serratus plane block PECISPB block is another regional nerve block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers a more complete pain blockade than the intercostal nerve block as it includes more nerves that supply the breast In addition to this the intercostal nerve block is a so-called blind-technique compared to the PECISPB block which is more accurately guided by ultrasound Blind techniques are associated with higher failure rates
Both the intercostal nerve block and the PECISPB nerve block have been used successfully at the Ottawa Hospital In this study the investigators propose a prospective double blinded randomized controlled head to head comparison of the PECISPB and intercostal nerve block to determine which block is associated with the best pain blockade and patient satisfaction in lattissimus dorsi flap surgery
Detailed Description:
Recent literature has unequivocally demonstrated that postoperative pain remains under-treated in hospitals While breast surgery remains one of the most common surgeries performed in hospitals today it has been shown that 40 of women still experience meaningful pain postoperatively It is well known that poor pain control is not only associated with slower recovery longer admission in hospital and poor patient satisfaction but it also can lead to the development of chronic post surgical pain
In recent years regional nerve blocks have emerged as a promising adjunct to standard postoperative analgesic ladder protocols The main advantage of regional anesthesia is the reduction of postoperative pain while limiting the amount of oral and intravenous narcotic use The reduction of postoperative narcotic use is advantageous for the patient and caregiver alike as it reduces common side effects associated with such medications such as drowsiness nausea vomiting upset stomach and dizziness
Regional anesthesia in breast reconstruction surgery commonly include thoracic epidurals intercostal nerve blocks and paravertebal nerve blocks To date there remains no standard of care for perioperative pain management and it is usually left to the discretion of the surgeon and anesthesiologist involved to decide which pain blockade is preferable on a case by case basis While paravertebral and intercostal nerve blocks have shown promising results they do not provide a complete sensory block to the anterior chest wall as innervation is supplied not only from the thoracic spinal nerves but also via medial and lateral pectoral nerves off the brachial plexus
The pectoral nerve block is a novel interfascial block placed into the plane between pectoralis major and minor muscles and is particularly useful in reconstructive breast surgery involving subpectoral prosthesis It has been associated with minimal analgesia postoperatively and is thought to be particularly useful in the daycare setting
To the best of the knowledge of the investigators the utility of the pectoral nerve block in pedicled Latissimus Dorsi breast reconstruction has not been investigated A mixed PEC I Serratus Plane Block provides analgesia to the lateral and medial pectoral nerves lateral and anterior branches of the T2-T4 spinal nerves long thoracic nerve and thoracodorsal nerve theoretically offering a more comprehensive block than the midaxillary intercostal block and with no additional morbidity to the patient Furthermore the intercostal nerve block is a blind technique that may be associated with higher failure rates compared to the more precise ultrasound guided PECISPB block
In this study the investigators plan to systematically investigate these two blocks in latissimus dorsi flap reconstruction in order to document optimal postoperative pain management
In recent years regional nerve blocks have emerged as a promising adjunct to standard postoperative analgesic ladder protocols The main advantage of regional anesthesia is the reduction of postoperative pain while limiting the amount of oral and intravenous narcotic use The reduction of postoperative narcotic use is advantageous for the patient and caregiver alike as it reduces common side effects associated with such medications such as drowsiness nausea vomiting upset stomach and dizziness
Regional anesthesia in breast reconstruction surgery commonly include thoracic epidurals intercostal nerve blocks and paravertebal nerve blocks To date there remains no standard of care for perioperative pain management and it is usually left to the discretion of the surgeon and anesthesiologist involved to decide which pain blockade is preferable on a case by case basis While paravertebral and intercostal nerve blocks have shown promising results they do not provide a complete sensory block to the anterior chest wall as innervation is supplied not only from the thoracic spinal nerves but also via medial and lateral pectoral nerves off the brachial plexus
The pectoral nerve block is a novel interfascial block placed into the plane between pectoralis major and minor muscles and is particularly useful in reconstructive breast surgery involving subpectoral prosthesis It has been associated with minimal analgesia postoperatively and is thought to be particularly useful in the daycare setting
To the best of the knowledge of the investigators the utility of the pectoral nerve block in pedicled Latissimus Dorsi breast reconstruction has not been investigated A mixed PEC I Serratus Plane Block provides analgesia to the lateral and medial pectoral nerves lateral and anterior branches of the T2-T4 spinal nerves long thoracic nerve and thoracodorsal nerve theoretically offering a more comprehensive block than the midaxillary intercostal block and with no additional morbidity to the patient Furthermore the intercostal nerve block is a blind technique that may be associated with higher failure rates compared to the more precise ultrasound guided PECISPB block
In this study the investigators plan to systematically investigate these two blocks in latissimus dorsi flap reconstruction in order to document optimal postoperative pain management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None