Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036979
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-09-07
Brief Title:
Preoperative Erector Spinae Plane Block Versus Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year Although it has a favorable prognosis with improved lines of treatment some complications may still disturb the patients life quality One of these complications is post-mastectomy pain syndrome PMPS Regional Anaesthesia RA is considered one of the most effective methods in reducing acute pain after breast surgeries these include pectoral nerves block PECS serratus anterior plane block SAPB paravertebral plane block PVPB and erector spinae plane block ESPB Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries
Detailed Description:
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year Although it has a favorable prognosis with improved lines of treatment some complications may still disturb the patients life quality One of these complications is post-mastectomy pain syndrome PMPS ¹
The International Association for Study of Pain IASP defines PMPS as chronic pain that persists more than 3 months in the anterior thorax axilla or upper arm ² It is usually neuropathic in nature includes altered sensations such as dysesthesia hypo or hyperesthesia allodynia or particular qualities of dysesthesia eg burning dull aching sensations It is usually of at least moderate intensity and may be either continuous or intermittent pain ³
The etiology and mechanism of PMPS remain incompletely clear yet Some risk factors are believed to be associated with PMPS including the presence and intensity of postoperative pain the type of surgery younger women prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴
Regional Anaesthesia RA is considered one of the most effective methods in reducing acute pain after breast surgeries these include pectoral nerves block PECS serratus anterior plane block SAPB paravertebral plane block PVPB and erector spinae plane block ESPB ⁵ Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period However clinically the role of RA in preventing PMPS is still under investigations ⁶
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae Paravertebral space is bounded by the parietal pleura superior costotransverse ligament vertebrae intervertebral foraminae and the heads of the ribs ⁷ While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸
Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling acute postoperative pain after breast surgeries some studies compared between them in controlling acute postoperative pain after breast surgeries ⁹ Also there are some studies that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast surgeries ¹⁰ but still the comparison between the effect of preoperative ESPB versus the effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries is still under investigated
Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries
The International Association for Study of Pain IASP defines PMPS as chronic pain that persists more than 3 months in the anterior thorax axilla or upper arm ² It is usually neuropathic in nature includes altered sensations such as dysesthesia hypo or hyperesthesia allodynia or particular qualities of dysesthesia eg burning dull aching sensations It is usually of at least moderate intensity and may be either continuous or intermittent pain ³
The etiology and mechanism of PMPS remain incompletely clear yet Some risk factors are believed to be associated with PMPS including the presence and intensity of postoperative pain the type of surgery younger women prior history of other types of pain and adjuvant therapies like chemo or radiotherapy ⁴
Regional Anaesthesia RA is considered one of the most effective methods in reducing acute pain after breast surgeries these include pectoral nerves block PECS serratus anterior plane block SAPB paravertebral plane block PVPB and erector spinae plane block ESPB ⁵ Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive input and central sensitization during the perioperative period However clinically the role of RA in preventing PMPS is still under investigations ⁶
PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves exit from the intervertebral foraminae Paravertebral space is bounded by the parietal pleura superior costotransverse ligament vertebrae intervertebral foraminae and the heads of the ribs ⁷ While ESPB includes injection of the local anesthetic in the fascial plane between the vertebral transverse processes and the erector spinae muscle ⁸
Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling acute postoperative pain after breast surgeries some studies compared between them in controlling acute postoperative pain after breast surgeries ⁹ Also there are some studies that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast surgeries ¹⁰ but still the comparison between the effect of preoperative ESPB versus the effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries is still under investigated
Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries
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