Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630858
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Intrathecal Morphine Vs Quadratus Lumborum Block for Pain in Laparoscopic Nephrectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Effects of Subcostal Anterior Quadratus Lumborum Block and Intrathecal Morphine on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery a Randomized Single-Blind Non-Inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block S-QLB3 and İntrathecal morphine ITM on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery
Detailed Description:
For all patients undergoing surgery analgesic medications and techniques are routinely administered preoperatively intraoperatively and postoperatively to relieve their pain Depending on the method applied patients analgesic needs in the recovery room and ward after surgery may vary In patients undergoing laparoscopic nephrectomy multimodal analgesia paracetamol nonsteroidal anti-inflammatory drugs and opioids is routinely applied in our clinic utilizing various regional techniques or intravenous analgesics
Opioids are the gold standard for postoperative pain control however they increase the incidence of opioid-related adverse effects such as dizziness nausea vomiting constipation and respiratory depression Therefore minimizing opioid use and its side effects is essential for postoperative pain control Regional analgesia is a beneficial method for reducing opioid consumption and postoperative pain It may also reduce postoperative morbidity and mortality
Recently interfascial plane blocks have been used for postoperative pain control in abdominal surgeries The quadratus lumborum block QLB is a relatively new interfascial plane block technique in which local anesthetics are injected adjacent to the quadratus lumborum muscle There are four different approaches to the QLB anterior intramuscular lateral and posterior Anterior QLB involves the injection of a local anesthetic between the quadratus lumborum QL muscle and the psoas muscle The dermatome coverage is determined by the injection site The injection of local anesthetic anterior to the QL muscle potentially allows the drug to spread into the thoracic paravertebral space blocking the somatic and sympathetic nerves of the lower thoracic segments This situation helps us achieve more effective analgesia in abdominal surgeries
Intrathecal morphine ITM is an emerging strategy for postoperative analgesia following major abdominal surgery Traditional spinal analgesia protocols often rely on continuous thoracic epidural anesthesia due to their ability to provide adequate analgesia with a few cardiopulmonary complications However epidural anesthesia is also associated with more frequent perioperative hypotension technical failures increased fluid administration and longer length of stay LOS Therefore ITM is an attractive alternative because it offers easier administration potent efficacy at low doses and reduced postoperative complications providing a form of spinal analgesia that can be used when epidural catheters are contraindicated
The analgesic properties of ITM have been demonstrated in recent studies involving cardiac gynecological spinal orthopedic urological colorectal hepatopancreatobiliary and major abdominal surgeries With an estimated duration of action of up to 24 hours these studies have focused on the initial postoperative recovery period and generally found lower pain scores and in some cases reduced early postoperative opioid requirements Intrathecal morphine has been successfully used for postoperative pain in various surgeries Being a hydrophilic opioid morphines limited sequestration in adipose tissue delays its clearance from the cerebrospinal fluid compared to other opioids As a result the analgesic effects of intrathecal morphine last longer providing up to 24 hours of analgesia without the need for indwelling catheters or continuous infusions Direct injection into the intrathecal space also allows morphine to act directly on opioid receptors in the brain and the substantia gelatinosa of the spinal cord providing a potent analgesic response
In this study it was aimed to determine whether the subcostal anterior quadratus lumborum block S-QLB3 is non-inferior to intrathecal morphine ITM in terms of postoperative 24-hour opioid consumption in patients undergoing laparoscopic nephrectomy
The H0 hypothesis of study is that the mean difference in postoperative 24-hour morphine consumption between S-QLB3 and ITM is less than or equal to the non-inferiority margin
Patients will be divided into two groups
Group S-QLB3A unilateral S-QLB3 block will be performed 04 mlkg of 025 bupivacaine 1400000 adrenaline In addition IV morphine-PCA will be applied postoperatively for 24 hours
Group ITM Intrathecal morphine will be performed 5 mcgkg preservative-free morphine maximum 200 mcg 75 mg isobaric bupivacaine In addition IV morphine-PCA will be applied postoperatively for 24 hours
Opioids are the gold standard for postoperative pain control however they increase the incidence of opioid-related adverse effects such as dizziness nausea vomiting constipation and respiratory depression Therefore minimizing opioid use and its side effects is essential for postoperative pain control Regional analgesia is a beneficial method for reducing opioid consumption and postoperative pain It may also reduce postoperative morbidity and mortality
Recently interfascial plane blocks have been used for postoperative pain control in abdominal surgeries The quadratus lumborum block QLB is a relatively new interfascial plane block technique in which local anesthetics are injected adjacent to the quadratus lumborum muscle There are four different approaches to the QLB anterior intramuscular lateral and posterior Anterior QLB involves the injection of a local anesthetic between the quadratus lumborum QL muscle and the psoas muscle The dermatome coverage is determined by the injection site The injection of local anesthetic anterior to the QL muscle potentially allows the drug to spread into the thoracic paravertebral space blocking the somatic and sympathetic nerves of the lower thoracic segments This situation helps us achieve more effective analgesia in abdominal surgeries
Intrathecal morphine ITM is an emerging strategy for postoperative analgesia following major abdominal surgery Traditional spinal analgesia protocols often rely on continuous thoracic epidural anesthesia due to their ability to provide adequate analgesia with a few cardiopulmonary complications However epidural anesthesia is also associated with more frequent perioperative hypotension technical failures increased fluid administration and longer length of stay LOS Therefore ITM is an attractive alternative because it offers easier administration potent efficacy at low doses and reduced postoperative complications providing a form of spinal analgesia that can be used when epidural catheters are contraindicated
The analgesic properties of ITM have been demonstrated in recent studies involving cardiac gynecological spinal orthopedic urological colorectal hepatopancreatobiliary and major abdominal surgeries With an estimated duration of action of up to 24 hours these studies have focused on the initial postoperative recovery period and generally found lower pain scores and in some cases reduced early postoperative opioid requirements Intrathecal morphine has been successfully used for postoperative pain in various surgeries Being a hydrophilic opioid morphines limited sequestration in adipose tissue delays its clearance from the cerebrospinal fluid compared to other opioids As a result the analgesic effects of intrathecal morphine last longer providing up to 24 hours of analgesia without the need for indwelling catheters or continuous infusions Direct injection into the intrathecal space also allows morphine to act directly on opioid receptors in the brain and the substantia gelatinosa of the spinal cord providing a potent analgesic response
In this study it was aimed to determine whether the subcostal anterior quadratus lumborum block S-QLB3 is non-inferior to intrathecal morphine ITM in terms of postoperative 24-hour opioid consumption in patients undergoing laparoscopic nephrectomy
The H0 hypothesis of study is that the mean difference in postoperative 24-hour morphine consumption between S-QLB3 and ITM is less than or equal to the non-inferiority margin
Patients will be divided into two groups
Group S-QLB3A unilateral S-QLB3 block will be performed 04 mlkg of 025 bupivacaine 1400000 adrenaline In addition IV morphine-PCA will be applied postoperatively for 24 hours
Group ITM Intrathecal morphine will be performed 5 mcgkg preservative-free morphine maximum 200 mcg 75 mg isobaric bupivacaine In addition IV morphine-PCA will be applied postoperatively for 24 hours
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