Postoperative PainNCT06612424
Quadratus Lumborum Block vs Intrathecal Morphine for Post-Cesarean Analgesia
A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK and İNTRATECHAL MORPHİNE GROUP in people with Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ANTERİOR QUADRATUS LUMBORUM BLOCK and İNTRATECHAL MORPHİNE GROUP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged between 18 and 40
- ASA 2 risk group
- Participants at 37-41 weeks of pregnancy
- undergoing cesarean section under spinal anesthesia
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital, Istanbul, 34000
Istanbul, 34255
About this study
Official title: 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
Read more
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
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- ANTERİOR QUADRATUS LUMBORUM BLOCK, İNTRATECHAL MORPHİNE GROUP
- Keywords
- intratechal morphine, anterior quadratus lumborum block, cesarean delivery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTERİOR QUADRATUS LUMBORUM BLOCKDrug
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.
İNTRATECHAL MORPHİNE GROUPDrug
In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| anterior quadratus lumborum block | Active comparator | 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. Receives: Drug: ANTERİOR QUADRATUS LUMBORUM BLOCK |
| intratechal morphine group | Active comparator | In the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine. Receives: Drug: İNTRATECHAL MORPHİNE GROUP |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the amount of total analgesic use in the first 24 hours in patients
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.)
Measured: 24 hour
Secondary outcomes (3)
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
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.
Measured: 24 hour
To compare postoperative side effects such as nausea, vomiting, and itching.
To compare postoperative side effects such as nausea, vomiting, and itching.
Measured: 24 hour
time to first rescue analgesic requirement.
Comparison of the time to first rescue analgesic requirement.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start22 Sep 2024
- Primary completion28 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
- Investigators
- Serpil Sehirlioglu, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612424
- Sponsor's protocol ID
- GaziosmanpasaTREH-ITM
- Status last verified
- May 2025
- First submitted
- 21 Sep 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested, it can be provided by contacting the corresponding author.
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.
PubMed 32251031Hussain 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.
PubMed 33206131
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum Block and Intrathecal Morphine Administration in Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT06612424
- Acronym / sponsor ID
- GaziosmanpasaTREH-ITM
- Conditions
- Postoperative Pain
- Keywords
- intratechal morphine, anterior quadratus lumborum block, cesarean delivery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 22 Sep 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anterior quadratus lumborum block | Active comparator | Drug: ANTERİOR QUADRATUS LUMBORUM BLOCKAll 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. |
| intratechal morphine group | Active comparator | Drug: İNTRATECHAL MORPHİNE GROUPIn the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants aged between 18 and 40
- ASA 2 risk group
- Participants at 37-41 weeks of pregnancy
- undergoing cesarean section under spinal anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANTERİOR QUADRATUS LUMBORUM BLOCKIn 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. | Drug | anterior quadratus lumborum block |
| İNTRATECHAL MORPHİNE GROUPIn the intrathecal morphine group, 100 micrograms of morphine (0.1 mL) will be added to the 12 mg of intrathecally administered bupivacaine. | Drug | intratechal morphine group |
Primary outcome
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.)
3 secondary outcomes
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 postoperative side effects such as nausea, vomiting, and itching.
Time frame: 24 hour
time to first rescue analgesic requirement.
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 32251031Sharpe 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.
- Results publication: PubMed 33206131Hussain 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.
- Individual participant dataSharing planned: No. If requested, it can be provided by contacting the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serpil Sehirlioglu principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK and İNTRATECHAL MORPHİNE GROUP in people with Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the amount of total analgesic use in the first 24 hours in patients (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.