Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965674
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2023-07-04
Brief Title:
Sacral Erector Spinae Plane Block Effect on Post-Hemorrhoidectomy Pain
Sponsor:
Konya City Hospital
Organization:
Konya City Hospital
Study Overview
Official Title:
The Effect of Sacral Erector Spinae Plane Block on Post-Hemorrhoidectomy Pain
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area characterized by symptoms such as pain bleeding and the presence of a protruding mass from the anal opening Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions Postoperative pain is a significant concern with over 80 of patients encountering moderate to severe pain
The main aim is to evaluate ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy It is also aimed if sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction In this prospective randomized controlled trial our main objective was to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy
The main aim is to evaluate ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy It is also aimed if sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction In this prospective randomized controlled trial our main objective was to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy
Detailed Description:
Hemorrhoids are commonly observed surgical conditions affecting the anorectal area characterized by symptoms such as pain bleeding and the presence of a protruding mass from the anal opening Fear of postoperative pain is one of the most important factors for patients to avoid surgical interventions Postoperative pain is a significant concern with over 80 of patients encountering moderate to severe pain This heightened pain level contributes to an elevated risk of complications including atelectasis thromboembolism myocardial ischemia cardiac arrhythmia electrolyte imbalance urinary retention and ileus The two main unresolved issues following surgery are postoperative pain and urinary retention In addition to improving patient satisfaction pain management will decrease urinary retention and constipation especially in the first 24 hours following surgery According to earlier research even with analgesic therapy 20 to 40 of patients who underwent hemorrhoidectomy would experience severe postoperative pain Commonly used pain relievers like nonsteroidal anti-inflammatory drugs paracetamol and opioids often come with adverse effects such as dizziness nausea vomiting and constipation and can even lead to tolerance These side effects could prevent a full recovery and result in a poor prognosis Bilateral pudendal nerve blocks are said to significantly reduce postoperative pain but they are technically difficult and require specific positioning Furthermore the administration of pudendal nerve block carries the risk of potential complications including hematoma formation sciatic nerve injury and accidental rectal puncture Therefore an alternative analgesic method with minimal adverse effects would be beneficial
The erector spinae plane block ESPB was initially introduced as an interfascial plane block performed at the upper thoracic levels with the purpose of alleviating neuropathic pain Subsequently its application expanded to encompass a range of thoracic interventions including mastectomy video-assisted thoracoscopy VATS and cardiac surgery while also being utilized at lumbar levels for procedures such as abdominal surgery prostatectomy lumbar spine surgery total hip arthroplasty and proximal femur surgery A newly introduced method called the sacral Erector Spinae Plane Block ESPB has been recently documented in scientific literature Case studies have demonstrated its effectiveness in various surgical procedures Specifically it has shown promise in managing radicular pain at the L5-S1 level after sex reassignment surgery and hypospadias surgery as well as providing analgesia for the posterior branches of the sacral nerves during pilonidal sinus surgery
The main hypothesis is that performing ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy It is also hypothesized that sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction In this prospective randomized controlled trial the main objective is to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy
The erector spinae plane block ESPB was initially introduced as an interfascial plane block performed at the upper thoracic levels with the purpose of alleviating neuropathic pain Subsequently its application expanded to encompass a range of thoracic interventions including mastectomy video-assisted thoracoscopy VATS and cardiac surgery while also being utilized at lumbar levels for procedures such as abdominal surgery prostatectomy lumbar spine surgery total hip arthroplasty and proximal femur surgery A newly introduced method called the sacral Erector Spinae Plane Block ESPB has been recently documented in scientific literature Case studies have demonstrated its effectiveness in various surgical procedures Specifically it has shown promise in managing radicular pain at the L5-S1 level after sex reassignment surgery and hypospadias surgery as well as providing analgesia for the posterior branches of the sacral nerves during pilonidal sinus surgery
The main hypothesis is that performing ESPB from the sacral level would result in effective analgesia following hemorrhoidectomy It is also hypothesized that sacral ESPB would reduce the use of additional analgesics after hemorrhoidectomy and increase patient satisfaction In this prospective randomized controlled trial the main objective is to examine the postoperative analgesic effects of sacral ESPB following hemorrhoidectomy
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