BlockPhase 4QLBNCT03428880
Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section
A Phase 4 study testing Morphine and Quadratus lumborum block in people with Block, run by University Tunis El Manar at 2 sites in Tunisia.
Trial summary
Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall… 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
- Block
- What is being tested?
- Morphine and Quadratus lumborum block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTunisia
- Study dates
- 15 Feb 2017to 20 Oct 2017
- Phase
- Phase 4
- 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
- ASA I/II.
- Normal singleton pregnancy with a gestation of at least 37 weeks.
Who cannot join
- Heart disease
- Coagulopathy
- pre-eclampsia
- BMI> 40
- Patient refusal to undergo the Quadratus lumborum block.
- Allergy to local anesthetics
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
Tunis maternity and neonatology center,
Tunis, 1007
About this study
Official title: Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery
Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects
Read the detailed description
In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.
After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.
Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.
Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.
Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.
The primary outcome measure was the total dose of morphine over 24 hours delivered by a patient-controlled analgesia system at predetermined intervals.
Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and sedation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called spinal morphine
spinal morphine is done before cesarean section
Quadratus lumborum blockDrug
Also called QLB
a US Block QLB is done after surgery
| Study group | Role | What they receive |
|---|---|---|
| spinal morphine | Active comparator | intrathecal morphine with 10 mg bupivacaine, 5 gamma sufenta and 100 gamma morphine. Intervention: In the end of surgery a QLB block is done with 20 ml of normal saline per side. Receives: Drug: Morphine |
| quadratus lumborum block | Active comparator | intrathecal anesthesia with10 mg bupivacaine, 5 gamma sufena and 1 ml normal saline.
Procedure : a quadratus lumborum block is done with 20 ml of bupivacaine 0,125% per side. Receives: Drug: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption over 24 hours postoperatively
Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.
Measured: Arrival to post anesthesia care unit until 24 hours posteratively
Secondary outcomes (3)
Time to first analgesic demand using PCA pump with morphine
recording the exact time to first analgesic demand by using the PCA with Morphine
Measured: Arrival to post anesthesia care unit until 24 hours posteratively
Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe
At predetermined intervalls, visual analog scale (VAS) pain scores at rest and at the palpation of the uterine globe were noted.
Measured: Arrival to post anesthesia care unit until 24 hours posteratively
Time to first deambulaton after surgery
After surgery, time when the patient was able to move from bed was noted.
Measured: Arrival to post anesthesia care unit until 24 hours posteratively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start15 Feb 2017
- Primary completion30 Sep 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayene Maghrebi, Professor, Study chair, tunis maternity center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428880
- Sponsor's protocol ID
- fel-bich
- Acronym
- QLB
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03428880
- Acronym / sponsor ID
- QLB / fel-bich
- Conditions
- Block
- Keywords
- quadratus lumborum block, cesarean section, spinal morphine, ultrasound guidance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 12 Feb 2018 (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.
Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects
Detailed description
In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.
After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.
Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.
Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.
Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.
The primary outcome measure was the total dose of morphine over 24 hours delivered by a patient-controlled analgesia system at predetermined intervals.
Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal morphine | Active comparator | Drug: Morphineintrathecal morphine with 10 mg bupivacaine, 5 gamma sufenta and 100 gamma morphine. Intervention: In the end of surgery a QLB block is done with 20 ml of normal saline per side. |
| quadratus lumborum block | Active comparator | Drug: Quadratus lumborum blockintrathecal anesthesia with10 mg bupivacaine, 5 gamma sufena and 1 ml normal saline. Procedure : a quadratus lumborum block is done with 20 ml of bupivacaine 0,125% per side. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I/II.
- Normal singleton pregnancy with a gestation of at least 37 weeks.
Key exclusion criteria (6 listed)
- Heart disease
- Coagulopathy
- pre-eclampsia
- BMI> 40
- Patient refusal to undergo the Quadratus lumborum block.
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 |
|---|---|---|
| MorphineAlso: spinal morphinespinal morphine is done before cesarean section | Drug | spinal morphine |
| Quadratus lumborum blockAlso: QLBa US Block QLB is done after surgery | Drug | quadratus lumborum block |
Primary outcome
Total morphine consumption over 24 hours postoperatively
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.
3 secondary outcomes
Time to first analgesic demand using PCA pump with morphine
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Time to first deambulaton after surgery
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
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 14 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hayene Maghrebi, Professor study chair
tunis maternity center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine and Quadratus lumborum block in people with Block, run by University Tunis El Manar at 2 sites in Tunisia.
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 2 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: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total morphine consumption over 24 hours postoperatively (time frame: Arrival to post anesthesia care unit until 24 hours posteratively). 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 14 Feb 2018.