AnesthesiaNCT06481462
Intrathecal Morphine vs. US-Guided Bilateral Posterior Quadratus Lumborum Block in Cesarean Section
An observational study of Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Postoperative Pain
- What is being tested?
- Intrathecal Morphine (ITM) and Quadratus Lumborum II (QLB-II) Block
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2024to 26 Dec 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: The study population consisted of pregnant women who were at least 37 weeks gestational age, aged between 18 and 45 years, with an ASA (American Society of Anesthesiologists) physical status score of II, scheduled for elective cesarean section under spinal anesthesia between July 1, 2024, and October 20, 2024, and who received either a posterior quadratus lumborum block (QLB-II) or intrathecal morphine.
Who may be able to join
- Pregnant for at least 37 weeks
- Aged between 18 and 45
- ASA (American Society of Anesthesiologists) physical status score II
- Patient planned for elective cesarean section under spinal anesthesia
- Patient receiving QLB-II block or intrathecal morphine
Who cannot join
- ASA score of III or IV.
- Planned cesarean section under general anesthesia.
- Requirement for conversion to general anesthesia after failed spinal anesthesia.
- Contraindication to spinal anesthesia and regional anesthesia techniques.
- BMI greater than 35 kg/m².
- History of opioid use disorder or opioid use for more than 4 weeks.
Show all 10Show fewer
- Inability to assess pain scores.
- Pregnancies of less than 37 weeks gestation.
- History of allergy to local anesthetics and systemic opioids.
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Posterior Quadratus Lumborum Block on Postoperative Acute Pain in Cesarean Section: A Prospective, Observational Study
In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.
Read the detailed description
Postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. An ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. Different options for pain control include central blocks, peripheral blocks, and systemic medications.
Intrathecal morphine (ITM) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. However, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. On the other hand, the Quadratus Lumborum Block (QLB), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. The aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (ITM) and Posterior Quadratus Lumborum in the management of acute postoperative pain after a cesarean section.
This study is a single-center, double-blind, prospective observational study.
Patients will be divided into 2 groups.
Group 1: The group receiving intrathecal morphine (ITM)
Group 2: The group receiving Posterior Quadratus Lumborum Block
In elective cesarean section cases under spinal anesthesia, the patient group receiving ITM and posterior QLB will be evaluated for obstetric general well-being during the first 24 hours and at discharge. Total morphine consumption in the first 24 hours, Pain scores (NRS) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.
- Conditions
- Anesthesia, Postoperative Pain
- Being tested
- Intrathecal Morphine (ITM), Quadratus Lumborum II (QLB-II) Block
- Keywords
- Cesarean section, intrathecal morphine, posterior quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Morphine (ITM)Procedure or surgery
morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl
Quadratus Lumborum II (QLB-II) BlockProcedure or surgery
12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | A subarachnoid block will be performed by injecting morphine 100 mcg + 12.5 mg hyperbaric bupivacaine + 20 mcg fentanyl. Receives: Procedure: Intrathecal Morphine (ITM) | |
| Posterior Quadratus Lumborum Block | Patients scheduled for elective cesarean section under spinal anesthesia will receive bilateral ultrasound-guided posterior quadratus lumborum block. Receives: Procedure: Quadratus Lumborum II (QLB-II) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4
Measured: Postoperative day 1
Secondary outcomes (5)
Postoperative pain scores
Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, and 24 hours after operation.The NRS is an 11-point numeric scale which ranges from 0 to 10.
Measured: Postoperative day 1
Postoperative nausea and vomiting (PONV) scores
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: Postoperative Day 1
The number of patient required rescue analgesic
The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 18, and 24 hours after operation
Measured: Postoperative Day 1
Postoperative pruritus score
Pruritus score: 0 = no pruritus; 1 = sensation of itching, but not scratching, just a rubbing sensation (mild); 2 = sensation of itching and scratching (moderate); 3 = sensation of pruritus, scratching, and requiring treatment (severe).
Measured: Postoperative Day 1
Patients' satisfaction and quality of pain management
Patients' pain management satisfaction and quality will be evaluated using the QoR-11 score. ObsQoR-11 is an 11-item questionnaire that is used to evaluate the recovery of parturient women after elective CS. ObsQoR-11 is evaluated in terms of the degree of post-operative pain, nausea, vomiting, activity, baby care, hygiene,and emotional control. Each item was scored using an 11-point system, with minimum and maximum scores of 0 and 110, respectively. A high score reflects good recovery.
QoR-11 Turkish Version will be used for assessment.
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start3 Jul 2024
- Primary completion26 Nov 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURHAN DOST, Ondokuz Mayıs University
- Investigators
- Burhan DOST, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481462
- Sponsor's protocol ID
- ITMQLB27
- Status last verified
- Feb 2025
- First submitted
- 25 Jun 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salama ER. Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial. Korean J Anesthesiol. 2020 Apr;73(2):121-128. doi: 10.4097/kja.d.18.00269. Epub 2019 Mar 8.
PubMed 30852882Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.
PubMed 29135590Ozkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.
PubMed 36443784
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Posterior Quadratus Lumborum Block on Postoperative Acute Pain in Cesarean Section: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06481462
- Acronym / sponsor ID
- ITMQLB27
- Conditions
- Anesthesia, Postoperative Pain
- Keywords
- Cesarean section, intrathecal morphine, posterior quadratus lumborum block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 1 Jul 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.
In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.
Detailed description
Postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. An ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. Different options for pain control include central blocks, peripheral blocks, and systemic medications.
Intrathecal morphine (ITM) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. However, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. On the other hand, the Quadratus Lumborum Block (QLB), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. The aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (ITM) and Posterior Quadratus Lumborum in the management of acute postoperative pain after a cesarean section.
This study is a single-center, double-blind, prospective observational study.
Patients will be divided into 2 groups.
Group 1: The group receiving intrathecal morphine (ITM)
Group 2: The group receiving Posterior Quadratus Lumborum Block
In elective cesarean section cases under spinal anesthesia, the patient group receiving ITM and posterior QLB will be evaluated for obstetric general well-being during the first 24 hours and at discharge. Total morphine consumption in the first 24 hours, Pain scores (NRS) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | – | Procedure: Intrathecal Morphine (ITM)A subarachnoid block will be performed by injecting morphine 100 mcg + 12.5 mg hyperbaric bupivacaine + 20 mcg fentanyl. |
| Posterior Quadratus Lumborum Block | – | Procedure: Quadratus Lumborum II (QLB-II) BlockPatients scheduled for elective cesarean section under spinal anesthesia will receive bilateral ultrasound-guided posterior quadratus lumborum block. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of pregnant women who were at least 37 weeks gestational age, aged between 18 and 45 years, with an ASA (American Society of Anesthesiologists) physical status score of II, scheduled for elective cesarean section under spinal anesthesia between July 1, 2024, and October 20, 2024, and who received either a posterior quadratus lumborum block (QLB-II) or intrathecal morphine.
Key inclusion criteria (5 listed)
- Pregnant for at least 37 weeks
- Aged between 18 and 45
- ASA (American Society of Anesthesiologists) physical status score II
- Patient planned for elective cesarean section under spinal anesthesia
- Patient receiving QLB-II block or intrathecal morphine
Key exclusion criteria (10 listed)
- ASA score of III or IV.
- Planned cesarean section under general anesthesia.
- Requirement for conversion to general anesthesia after failed spinal anesthesia.
- Contraindication to spinal anesthesia and regional anesthesia techniques.
- BMI greater than 35 kg/m².
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 |
|---|---|---|
| Intrathecal Morphine (ITM)morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl | Procedure or surgery | Intrathecal Morphine |
| Quadratus Lumborum II (QLB-II) Block12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine | Procedure or surgery | Posterior Quadratus Lumborum Block |
Primary outcome
Morphine consumption in the first 24 hours after surgery
Time frame: Postoperative day 1
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4
5 secondary outcomes
Postoperative pain scores
Time frame: Postoperative day 1
Postoperative nausea and vomiting (PONV) scores
Time frame: Postoperative Day 1
The number of patient required rescue analgesic
Time frame: Postoperative Day 1
Postoperative pruritus score
Time frame: Postoperative Day 1
Patients' satisfaction and quality of pain management
Time frame: Postoperative Day 1
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 25 Feb 2025.
- Background: PubMed 30852882Salama ER. Ultrasound-guided bilateral quadratus lumborum block vs. intrathecal morphine for postoperative analgesia after cesarean section: a randomized controlled trial. Korean J Anesthesiol. 2020 Apr;73(2):121-128. doi: 10.4097/kja.d.18.00269. Epub 2019 Mar 8.
- Background: PubMed 29135590Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.
- Background: PubMed 36443784Ozkan G, Kara U, Ince ME, Ozdemir O, Ulubay M, Senkal S. Validation of the Turkish version of the Obstetric Quality-of-Recovery score 11 (ObsQoR-11T) after cesarean delivery. Health Qual Life Outcomes. 2022 Nov 28;20(1):155. doi: 10.1186/s12955-022-02073-y.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Burhan DOST study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University 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 5 inclusion and 10 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 25 Feb 2025. 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?
Morphine consumption in the first 24 hours after surgery (time frame: Postoperative day 1). 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 NCT06481462, which also lists 3 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 25 Feb 2025.