Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612424
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Quadratus Lumborum Block vs Intrathecal Morphine for Post-Cesarean Analgesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum Block and Intrathecal Morphine Administration in Cesarean Deliveries
Status:
RECRUITING
Status Verified Date:
2024-09
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:
İn this study planned to compare the post-operative analgesic efficacy of Intrathecal Morphine Administration and anterior Quadratus lumborum Block in elective cesarean section operations
this study primary aim is To compare the NRS Numering rating scale values resting and dynamic at 2 4 8 12 24 hours in the postoperative follow-up of the patients after anterior Quadratus lumborum block and Intrathecal morphine administration for postoperative analgesia after elective cesarean section operations under spinal anesthesia
Our secondary aims are 1 To compare and evaluate the first rescue analgesia requirement times 2 To compare the amount of total analgesic use in the first 24 hours in patients 3 Comparing the side effects such as postoperative nausea and vomiting
this study primary aim is To compare the NRS Numering rating scale values resting and dynamic at 2 4 8 12 24 hours in the postoperative follow-up of the patients after anterior Quadratus lumborum block and Intrathecal morphine administration for postoperative analgesia after elective cesarean section operations under spinal anesthesia
Our secondary aims are 1 To compare and evaluate the first rescue analgesia requirement times 2 To compare the amount of total analgesic use in the first 24 hours in patients 3 Comparing the side effects such as postoperative nausea and vomiting
Detailed Description:
Participants scheduled for elective cesarean sections under spinal anesthesia will be divided into three groups anterior Quadratus Lumborum block QLB intrathecal morphine and control groups using the sealed-envelope randomization method All participants will receive detailed information and provide informed consent Anesthesia for all patients will be administered under spinal anesthesia Spinal anesthesia will be performed with 12 mg of bupivacaine injected intrathecally at the L3-4 or L4-5 intervertebral space using a 25G spinocan needle
In the intrathecal morphine group 100 micrograms of morphine 01 mL will be added to the 12 mg of intrathecally administered bupivacaine In the QLB and control groups intrathecal morphine will not be administered and 01 mL of saline will be added to 12 mg of bupivacaine instead In the anterior QLB block group the block will be performed postoperatively Participants in the QLB group will be taken to the postoperative block room at the end of the surgery
All blocks will be performed by the same anesthesiologist using ultrasound guidance In the Quadratus Lumborum block group participants will be placed in the lateral decubitus position A convex ultrasound probe will be placed in sterile conditions along the midaxillary line in the subcostal area above the iliac crest to visualize the quadratus lumborum and psoas major muscles as well as the L4 vertebral transverse process Using an in-plane technique a 22G 100 mm peripheral block needle will be advanced anterior to the quadratus lumborum muscle and into the subfascial space between the quadratus lumborum and psoas major muscles After confirming the correct location with hydrodissection 25 mL of 025 bupivacaine will be injected slowly observing the fascial displacement on ultrasound The same procedure will be repeated on the contralateral side All patients will be monitored in the block room for 30 minutes post-procedure
The control and intrathecal morphine groups will not receive any postoperative interventions At the end of the surgery once the modified Aldrete score is greater than 8 participants will be transferred to the ward due to the spinal anesthesia Postoperatively when the spinal anesthesia level recedes by two dermatomes patients will receive 1g of intravenous paracetamol for analgesia The postoperative analgesic regimen will include paracetamol 1g every 6 hours 4x1g In participants with NRS Numerical Rating Scale scores greater than 3 during postoperative follow-up 75 mg of intravenous diclofenac sodium will be administered as rescue analgesia in the ward
Participants will be evaluated at 2 4 8 12 and 24 hours postoperatively by a blinded anesthesiologist different from the one who performed the block Resting and dynamic NRS scores rated on a scale of 0-10 where 0 indicates no pain and 10 indicates the most severe pain dynamic NRS scores will be assessed by asking the patient to cough will be recorded along with the total amount of analgesics used in the first 24 hours postoperatively and the incidence of nausea vomiting and pruritus will also be evaluated
In the intrathecal morphine group 100 micrograms of morphine 01 mL will be added to the 12 mg of intrathecally administered bupivacaine In the QLB and control groups intrathecal morphine will not be administered and 01 mL of saline will be added to 12 mg of bupivacaine instead In the anterior QLB block group the block will be performed postoperatively Participants in the QLB group will be taken to the postoperative block room at the end of the surgery
All blocks will be performed by the same anesthesiologist using ultrasound guidance In the Quadratus Lumborum block group participants will be placed in the lateral decubitus position A convex ultrasound probe will be placed in sterile conditions along the midaxillary line in the subcostal area above the iliac crest to visualize the quadratus lumborum and psoas major muscles as well as the L4 vertebral transverse process Using an in-plane technique a 22G 100 mm peripheral block needle will be advanced anterior to the quadratus lumborum muscle and into the subfascial space between the quadratus lumborum and psoas major muscles After confirming the correct location with hydrodissection 25 mL of 025 bupivacaine will be injected slowly observing the fascial displacement on ultrasound The same procedure will be repeated on the contralateral side All patients will be monitored in the block room for 30 minutes post-procedure
The control and intrathecal morphine groups will not receive any postoperative interventions At the end of the surgery once the modified Aldrete score is greater than 8 participants will be transferred to the ward due to the spinal anesthesia Postoperatively when the spinal anesthesia level recedes by two dermatomes patients will receive 1g of intravenous paracetamol for analgesia The postoperative analgesic regimen will include paracetamol 1g every 6 hours 4x1g In participants with NRS Numerical Rating Scale scores greater than 3 during postoperative follow-up 75 mg of intravenous diclofenac sodium will be administered as rescue analgesia in the ward
Participants will be evaluated at 2 4 8 12 and 24 hours postoperatively by a blinded anesthesiologist different from the one who performed the block Resting and dynamic NRS scores rated on a scale of 0-10 where 0 indicates no pain and 10 indicates the most severe pain dynamic NRS scores will be assessed by asking the patient to cough will be recorded along with the total amount of analgesics used in the first 24 hours postoperatively and the incidence of nausea vomiting and pruritus will also be evaluated
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