Outcome MeasuresNCT05643846
Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics
A study testing QLB procedure after cesarean section in people with Outcome Measures, run by Danat Al Emarat Hospital at 1 site in United Arab Emirates.
Trial summary
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. 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
- Outcome Measures
- What is being tested?
- QLB procedure after cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 27 Feb 2023to 6 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 who are American Society of Anesthesiologists physical status 1 or 2.
- Participants who have singleton pregnancy at a gestation of at least 37 weeks.
- Participant who are scheduled for elective caesarean section under spinal anesthesia.
- Participants who are consented to be enrolled into the study.
Who cannot join
- Patients who have contraindications to spinal or regional anesthesia (Coagulopathy or on anticoagulants).
- Who have Allergy or sensitivity to study medications.
- Who have anatomical abnormalities or localized infection.
- Who have history of chronic pain or on regular opioids use.
- Who are unable to comprehend or unable to use the verbal rating pain scoring system,
- Failed spinal anesthesia or conversion to general anesthesia after spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics. A Randomized Clinical Trial
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. This central effect can be of vital importance when managing the visceral pain after caesarean section.
Many studies have shown that the inclusion of quadratus lumborum block to a multimodal analgesic regimen would reduce pain scores, opioid consumption, and prolonging time to first rescue analgesic after cesarean delivery.
Read more
However, the dose and concentration of the local anesthetic used among the studies are varied, and literature search identified no randomized controlled trial which looked at the concentration -response of local anesthetic to optimize the concentration resulting in the best pain relief.
It is a perspective randomized controlled trial to compare the analgesic efficacy of 2 different concentrations of Bupivacaine to standardize postoperative analgesic protocol used for QLB after caesarean section.
Read the detailed description
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. Acute post C-section pain is a leading anesthetic concern for women; a key determinant of maternal satisfaction; may lead to persistent postoperative pain; is a predictor of postpartum depression; and can reduce early breastfeeding success. Effective postoperative analgesia should, therefore, be prioritized to improve outcomes following caesarean delivery. This study is a Double-blinded, randomized and controlled trial.
A written, informed consent is discussed with and signed by all participants, and the participants are randomly assigned into one of two groups; (Group 1) to receive bilateral QLB with '0.125% bupivacaine 0.2 ml/ kg', (Group 2) to receive bilateral QLB with '0.25% bupivacaine 0.2 ml/kg'. For all participants, spinal anesthesia is performed with ultrasonography guidance in a standardized manner using hyperbaric bupivacaine 15mg and fentanyl 25 μg.
At the end of the procedure in the supine position, all participants receive bilateral QLBs performs under ultrasound guidance and aseptic technique. The internal oblique muscle is identified and followed laterally to the lateral interfacial triangle sitting above the quadratus lumborum muscle.
Results will be reported as
- Total number of PCA morphine demands and the actual doses delivered at predetermined time intervals (1h, 2 h, 4h, 6 h, 12 h, 24 h and 48 h) after surgery
- Record of supplemental and regular analgesics.
- Visual analogue score for pain at rest (static) and with movement (dynamic) (defined as the elevation of the head and shoulders off the pillow from the supine position), (0, no pain; 10, worst pain imaginable).
- Residual nerve block (the time to mobilization)
- Block-related complications (i.e., hematoma, organ injury, local anesthetic systemic toxicity, and sepsis).
6- Opioids-related side effects (Nausea, Vomiting, Itching)
The investigators hypothesized that using a higher concentration (0.25%) of local anesthetic (Bupivacaine) would increase the analgesic effect without increasing the side effects and complications.
- Conditions
- Outcome Measures
- Being tested
- QLB procedure after cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLB procedure after cesarean sectionProcedure or surgery
Also called Bupivacaine Local anesthetic drug at concentrations of 0.125% or 0.25%, Marcaine local anesthetic drug at concentration of 0.125% or 0.25%, at a dose of 0.2ml/kg
Bupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| (Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'. | Active comparator | (Group 1) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at concentration of 0.125% concentration, at a dose of 0.2 ml/kg'. Receives: Procedure: QLB procedure after cesarean section |
| (Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'. | Active comparator | (Group 2) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at a concentration of 0.25% concentration, at a dose of 0.2 ml/kg'. Receives: Procedure: QLB procedure after cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine dose requirements for pain control after surgery
Actual doses of PCA morphine, in milligram unit, delivered to the participant after surgery on Day 0, Day1, and on Day2 after surgery.
Measured: Day 0, Day1, Day 2 after surgery.
Total number of morphine demands after surgery.
Total number of PCA morphine demands after surgery on Day 0, on Day1, and on Day2 after surgery.
Measured: Day 0, Day1, Day 2 after surgery.
Assessment of heart rate changes from baseline after surgery.
Measurement of heart rate in Beat per minutes changes from baseline after surgery. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Measured: Day 0, On Day1, and on Day 2 after surgery.
Assessment of respiratory rate changes from baseline.
Measurement of respiratory rate in breath per minutes changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Measured: Day 0, On Day1, and on Day 2 after surgery.
Assessment of Oxygen saturation changes from baseline.
Measurement of oxygen saturation percentage changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Measured: Day 0 after surgery, on Day1, and on Day2 after surgery.
Noninvasive blood pressure changes from baseline after surgery.
Noninvasive Measurement of blood pressure after surgery in Milliliter of mercury changes from baseline. Measurement of Systolic and diastolic blood pressure changes on Day 0 after surgery, on Day1, and on Day2 after surgery.
Measured: Day 0 after surgery, on Day1, and on Day2 after surgery.
Secondary outcomes (3)
Post operative Pain score
Pain scale used are "Visual analogue score' for pain assessment at rest, and "visual analogue score' for pain assessment with movement. Pain scale scores (assessment during movement and during rest), are from 0 to 10. Pain score of 0 means no pain, which indicate that the 'Quadratus lumborum block is very effective (desired outcome). Pain score of 10 means worst imaginable pain, which indicate that the block is not effective (Undesired outcome).
Measured: On Day 0, On Day1, and on Day 2.
Measurement of Time to mobilization in hours after surgery.
Recording of the time when the patient is able to stand on her legs and move out of the bed alone after the surgery. Time to mobilization in hours up to 48th hour after surgery. Early mobilization indicates successful block of pain after surgery without affecting lumber plexus nerves (desired outcome).
Delayed mobilization indicates block extending to lumber plexus nerves (Undesired outcome).
Measured: From 1st hour up to 48th hour after surgery.
Assessment of Nausea and Vomiting postoperative.
"Nausea scale", the Nausea scale score is from 0 to 3, when score of: 0 indicate No Nausea, score of 1 indicate mild nausea without vomiting, score of 2 indicate moderate nausea without vomiting, and score of 3 indicate severe nausea with vomiting (Undesired outcome).
Assessment at hours 1st, 2nd, 4th, 8th, 12th, 24th, and at 48th hour after surgery.
Measured: From 1st hour up to 48th hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start27 Feb 2023
- Primary completion6 Sep 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome MeasuresStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a Prospective, Double-blinded, randomized and controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danat Al Emarat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JINAN AHMED JAMEEL AL ALOOSI, Danat Al Emarat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643846
- Sponsor's protocol ID
- RP DAE/2022/102
- Status last verified
- Dec 2024
- First submitted
- 27 Oct 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05643846
- Acronym / sponsor ID
- RP DAE/2022/102
- Conditions
- Outcome Measures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Danat Al Emarat HospitalUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 6 Sep 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. This central effect can be of vital importance when managing the visceral pain after caesarean section.
Many studies have shown that the inclusion of quadratus lumborum block to a multimodal analgesic regimen would reduce pain scores, opioid consumption, and prolonging time to first rescue analgesic after cesarean delivery.
However, the dose and concentration of the local anesthetic used among the studies are varied, and literature search identified no randomized controlled trial which looked at the concentration -response of local anesthetic to optimize the concentration resulting in the best pain relief.
It is a perspective randomized controlled trial to compare the analgesic efficacy of 2 different concentrations of Bupivacaine to standardize postoperative analgesic protocol used for QLB after caesarean section.
Detailed description
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and paravertebral space. Acute post C-section pain is a leading anesthetic concern for women; a key determinant of maternal satisfaction; may lead to persistent postoperative pain; is a predictor of postpartum depression; and can reduce early breastfeeding success. Effective postoperative analgesia should, therefore, be prioritized to improve outcomes following caesarean delivery. This study is a Double-blinded, randomized and controlled trial.
A written, informed consent is discussed with and signed by all participants, and the participants are randomly assigned into one of two groups; (Group 1) to receive bilateral QLB with '0.125% bupivacaine 0.2 ml/ kg', (Group 2) to receive bilateral QLB with '0.25% bupivacaine 0.2 ml/kg'. For all participants, spinal anesthesia is performed with ultrasonography guidance in a standardized manner using hyperbaric bupivacaine 15mg and fentanyl 25 μg.
At the end of the procedure in the supine position, all participants receive bilateral QLBs performs under ultrasound guidance and aseptic technique. The internal oblique muscle is identified and followed laterally to the lateral interfacial triangle sitting above the quadratus lumborum muscle.
Results will be reported as
- Total number of PCA morphine demands and the actual doses delivered at predetermined time intervals (1h, 2 h, 4h, 6 h, 12 h, 24 h and 48 h) after surgery
- Record of supplemental and regular analgesics.
- Visual analogue score for pain at rest (static) and with movement (dynamic) (defined as the elevation of the head and shoulders off the pillow from the supine position), (0, no pain; 10, worst pain imaginable).
- Residual nerve block (the time to mobilization)
- Block-related complications (i.e., hematoma, organ injury, local anesthetic systemic toxicity, and sepsis).
6- Opioids-related side effects (Nausea, Vomiting, Itching)
The investigators hypothesized that using a higher concentration (0.25%) of local anesthetic (Bupivacaine) would increase the analgesic effect without increasing the side effects and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a Prospective, Double-blinded, randomized and controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| (Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'. | Active comparator | Procedure: QLB procedure after cesarean section(Group 1) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at concentration of 0.125% concentration, at a dose of 0.2 ml/kg'. |
| (Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'. | Active comparator | Procedure: QLB procedure after cesarean section(Group 2) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at a concentration of 0.25% concentration, at a dose of 0.2 ml/kg'. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who are American Society of Anesthesiologists physical status 1 or 2.
- Participants who have singleton pregnancy at a gestation of at least 37 weeks.
- Participant who are scheduled for elective caesarean section under spinal anesthesia.
- Participants who are consented to be enrolled into the study.
Key exclusion criteria (6 listed)
- Patients who have contraindications to spinal or regional anesthesia (Coagulopathy or on anticoagulants).
- Who have Allergy or sensitivity to study medications.
- Who have anatomical abnormalities or localized infection.
- Who have history of chronic pain or on regular opioids use.
- Who are unable to comprehend or unable to use the verbal rating pain scoring system,
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 |
|---|---|---|
| QLB procedure after cesarean sectionAlso: Bupivacaine Local anesthetic drug at concentrations of 0.125% or 0.25%, Marcaine local anesthetic drug at concentration of 0.125% or 0.25%, at a dose of 0.2ml/kgBupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg. | Procedure or surgery | (Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'., (Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'. |
Primary outcome
Morphine dose requirements for pain control after surgery
Time frame: Day 0, Day1, Day 2 after surgery.
Actual doses of PCA morphine, in milligram unit, delivered to the participant after surgery on Day 0, Day1, and on Day2 after surgery.
Total number of morphine demands after surgery.
Time frame: Day 0, Day1, Day 2 after surgery.
Total number of PCA morphine demands after surgery on Day 0, on Day1, and on Day2 after surgery.
Assessment of heart rate changes from baseline after surgery.
Time frame: Day 0, On Day1, and on Day 2 after surgery.
Measurement of heart rate in Beat per minutes changes from baseline after surgery. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Assessment of respiratory rate changes from baseline.
Time frame: Day 0, On Day1, and on Day 2 after surgery.
Measurement of respiratory rate in breath per minutes changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Assessment of Oxygen saturation changes from baseline.
Time frame: Day 0 after surgery, on Day1, and on Day2 after surgery.
Measurement of oxygen saturation percentage changes from baseline. On Day 0 after surgery, on Day1, and on Day2 after surgery.
Noninvasive blood pressure changes from baseline after surgery.
Time frame: Day 0 after surgery, on Day1, and on Day2 after surgery.
Noninvasive Measurement of blood pressure after surgery in Milliliter of mercury changes from baseline. Measurement of Systolic and diastolic blood pressure changes on Day 0 after surgery, on Day1, and on Day2 after surgery.
3 secondary outcomes
Post operative Pain score
Time frame: On Day 0, On Day1, and on Day 2.
Measurement of Time to mobilization in hours after surgery.
Time frame: From 1st hour up to 48th hour after surgery.
Assessment of Nausea and Vomiting postoperative.
Time frame: From 1st hour up to 48th hour after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLB procedure after cesarean section in people with Outcome Measures, run by Danat Al Emarat Hospital at 1 site in United Arab Emirates.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. 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 United Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
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 dose requirements for pain control after surgery (time frame: Day 0, Day1, Day 2 after surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.