Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02339766
Status:
TERMINATED
Last Update Posted:
2021-10-22
First Post:
2015-01-06
Brief Title:
Quadratus Lumborum Block for Post-Cesarean Analgesia
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not feasible due to difficulty with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Most women having planned cesarean section receive spinal anesthetic for the procedure
Typically spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively However spinal opioids are frequently associated with adverse effects such as nausea pruritus sedation and occasionally respiratory depression
The quadratus lumborum QL block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids There is some evidence that it may provide visceral along with somatic pain relief It is a simple and safe technique that has been studied in lower abdominal surgeries but has not been studied for pain relief after cesarean section
If found effective it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia This block has evolved from the previously known transversus abdominis plane block
We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine We will also study if it provides any incremental benefit when administered in addition to spinal morphine
Typically spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively However spinal opioids are frequently associated with adverse effects such as nausea pruritus sedation and occasionally respiratory depression
The quadratus lumborum QL block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids There is some evidence that it may provide visceral along with somatic pain relief It is a simple and safe technique that has been studied in lower abdominal surgeries but has not been studied for pain relief after cesarean section
If found effective it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia This block has evolved from the previously known transversus abdominis plane block
We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine We will also study if it provides any incremental benefit when administered in addition to spinal morphine
Detailed Description:
This will be a randomized controlled double blinded trial
Seventy five female patients belonging to American Society of Anesthesiologists status 1-3 age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study
After obtaining informed consent they will be randomized to one of the three groups by a computer-generated randomization All patients will receive standard spinal anesthetic They will be randomized to one of the three groups n25 per group
Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic Group 2 will receive equal volume of saline added to the intrathecal mixture
Ultrasound guided Quadratus Lumborum block will be done Following negative aspiration 25 mL of Ropivacaine 05 Groups 2 and 3 or the same amount of saline Group 1 will be injected in each side
All patients will receive routine postoperative analgesia including analgesics and oral morphine
All patients will be assessed postoperatively by a blinded investigator at 6 12 and 24h post-operatively
Seventy five female patients belonging to American Society of Anesthesiologists status 1-3 age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study
After obtaining informed consent they will be randomized to one of the three groups by a computer-generated randomization All patients will receive standard spinal anesthetic They will be randomized to one of the three groups n25 per group
Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic Group 2 will receive equal volume of saline added to the intrathecal mixture
Ultrasound guided Quadratus Lumborum block will be done Following negative aspiration 25 mL of Ropivacaine 05 Groups 2 and 3 or the same amount of saline Group 1 will be injected in each side
All patients will receive routine postoperative analgesia including analgesics and oral morphine
All patients will be assessed postoperatively by a blinded investigator at 6 12 and 24h post-operatively
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