- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06612424
Quadratus Lumborum Block vs Intrathecal Morphine for Post-Cesarean Analgesia
Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum Block and Intrathecal Morphine Administration in Cesarean Deliveries
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 amount of total analgesic use in the first 24 hours in patients
Our secondary aims are: 1.) To compare and evaluate the first rescue analgesia requirement times 2.) 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.
3.) Comparing the side effects such as postoperative nausea and vomiting
Study Overview
Status
Conditions
Intervention / Treatment
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 (0.1 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 0.1 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 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, 20 mL of 0.25% 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 PACU 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. Diclofenac was not to be administered more than twice daily, and if the NRS score remained ≥4 despite two doses, intravenous tramadol at a dose of 1 mg/kg was planned.
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34255
- Gaziosmanpasa Research and Education Hospital, Istanbul, 34000
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Inclusion Criteria:
- Participants aged between 18 and 40
- ASA 2 risk group
- Participants at 37-41 weeks of pregnancy
- undergoing cesarean section under spinal anesthesia
Exclusion Criteria:
- The participant does not accept the procedure.
- Patients with a history of eclampsia and preeclampsia during pregnancy
- local anesthetic allergy
- Infection at the procedure site
- Anticoagulant use with bleeding disorder
- Chronic analgesia and opioid use
- Mental, psychiatric and neurological problems -Participant with ASA 3 and above with a history of any chronic disease. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intratechal morphine group
In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.
|
In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.
|
|
No Intervention: control group
Participants in the control group will not receive any interventions such as intrathecal morphine or quadratus lumborum block.
They will undergo cesarean sections under spinal anesthesia.
|
|
|
Active Comparator: anterior quadratus lumborum block
All blocks will be performed by the same anesthesiologist using ultrasound guidance.
In the Quadratus Lumborum block group, patients 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, 20 mL of 0.25% bupivacaine will be injected slowly, observing the fascial displacement on ultrasound.
The same procedure will be repeated on the contralateral side.
|
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, 20 mL of 0.25% bupivacaine will be injected slowly, observing the fascial displacement on ultrasound.
The same procedure will be repeated on the contralateral side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparing the amount of total analgesic use in the first 24 hours in patients
Time Frame: 24 hour
|
For all Participants, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Participants with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with diclofenac sodium 75 mg at a dose intravenos.The total diklofenac sodium consumption of participants within the first 24 hours will be compared. (At initial trial registration, postoperative NRS pain scores were specified as the primary outcome. During the study phase, total postoperative analgesic consumption was used as the primary outcome for statistical planning, analysis, and reporting. The trial registration was updated to ensure consistency between registered outcomes and analyses. NRS pain scores were analyzed as secondary outcomes. This update was not based on study results.) |
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare postoperative side effects such as nausea, vomiting, and itching.
Time Frame: 24 hour
|
To compare postoperative side effects such as nausea, vomiting, and itching.
|
24 hour
|
|
time to first rescue analgesic requirement.
Time Frame: 24 hour
|
Comparison of the time to first rescue analgesic requirement.
|
24 hour
|
|
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
Time Frame: 24 hour
|
To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores reflect greater pain intensity.
|
24 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Serpil Sehirlioglu, Gaziosmanpasa Research and Education Hospital
Publications and helpful links
General Publications
- Sharpe EE, Molitor RJ, Arendt KW, Torbenson VE, Olsen DA, Johnson RL, Schroeder DR, Jacob AK, Niesen AD, Sviggum HP. Intrathecal Morphine versus Intrathecal Hydromorphone for Analgesia after Cesarean Delivery: A Randomized Clinical Trial. Anesthesiology. 2020 Jun;132(6):1382-1391. doi: 10.1097/ALN.0000000000003283.
- Hussain N, Brull R, Weaver T, Zhou M, Essandoh M, Abdallah FW. Postoperative Analgesic Effectiveness of Quadratus Lumborum Block for Cesarean Delivery under Spinal Anesthesia. Anesthesiology. 2021 Jan 1;134(1):72-87. doi: 10.1097/ALN.0000000000003611.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics
- Analgesics, Opioid
- Narcotics
- Morphine
Other Study ID Numbers
- GaziosmanpasaTREH-ITM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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