Quadratus Lumborum BlockNCT03695588
Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section
A study testing Quadratus lumborum block in people with Quadratus Lumborum Block, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial summary
There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quadratus Lumborum Block
- What is being tested?
- Quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIreland
- Study dates
- 30 Oct 2018to 24 Apr 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Caesarean section under spinal anaesthesia.
- Age > 18 years old.
- Singleton pregnancy.
Who cannot join
- Contraindication to spinal or regional anaesthesia.
- Allergy/sensitivity/contraindication to study medications.
- Unable to comprehend visual analogue scale.
- BMI > 40.
- Booking weight <40kg.
- History of chronic pain or regular opioid use.
- Pre-eclampsia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section: A Prospective, Double-blind, Randomised Controlled Trial.
There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.
Read the detailed description
Post-operative pain relief management remains challenging after Caesarean-section. The perfect postoperative analgesic regimen is yet to be elucidated, but opioids remain a cornerstone whether they are administered intra-thecally, or systemically or both. Unfortunately, opioids are associated with significant adverse effects such as respiratory depression, post-operative nausea and vomiting (PONV), sedation and pruritus. Therefore, the search for opioid sparing analgesic techniques is important.
The study treatment consists of a quadratus lumborum block (QLB) of either 0.25% Levobupivacaine or a simulated sham QLB after C-section under spinal anaesthesia. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope.
Spinal anaesthesia will be performed in a standardised manner using 10-15mg hyperbaric bupivacaine, 20ug fentanyl and 100ug preservative free morphine. Anaesthetic and surgical management will be conducted as per the usual manner. Diclofenac 100mg suppositories and IV Paracetamol 1g will be administered at the end of surgery. A Morphine PCA will be connected to the patient in the recovery room after the intervention.
The bilateral posterior QLB will be performed after surgery in the supine position in an aseptic manner. The patient will be blinded to the group intervention as the sterile drapes will be left hanging blocking the patient's view of the procedure. The block from the spinal anaesthetic will mean the patient is unaware of the procedure being carried out. A curvilinear ultrasound probe will be used to identify the quadratus lumborum muscle.
Intervention group:
Aseptic, ultrasound guided, bilateral QLB using a posterior approach. This is known as the QLB 2 approach. A maximum volume of 20 ml of 0.25% Levobupivacaine will be administered each side. After the procedure a sterile dressing will be placed on the puncture site.
Placebo group:
The patient will be sterilized, draped and scanned in the same manner as the intervention group, until the target injection point is identified. The operator will use a blunt needle to apply pressure to the skin, (without breaking the skin), for one minute as if they are performing the procedure. This will be performed bilaterally. After the procedure, a sterile dressing will be placed over the pressure area.
- Conditions
- Quadratus Lumborum Block
- Being tested
- Quadratus lumborum block, Sham QLB
- Keywords
- pain relief, Caesarean, Cesarean, c-section, intrathecal morphine, analgesia, QLB, QL, QLB2, QL2
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)
Sham QLBProcedure or surgery
Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Active comparator | Bilateral posterior QLB with 20ml 0.25% L-Bupivacaine. Receives: Procedure: Quadratus lumborum block |
| Sham QLB | Sham comparator | Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block. Receives: Procedure: Sham QLB |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV PCA Morphine consumption up to 24 hours.
Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.
Measured: 24 hours
Secondary outcomes (7)
Pain scores at rest.
VAS (visual analogue scale) pain scores at rest - lying supine in bed.
Measured: 6, 12, 24, 48 hours
Pain scores on movement.
VAS pain scores on movement - raising head and shoulders off pillow when lying supine in bed.
Measured: 6, 12, 24, 48 hours
Nausea and vomiting.
The incidence of N+V requiring rescue anti-emetics.
Measured: 24, 48 hours
IV PCA morphine bolus demands.
Intravenous PCA (patient controlled analgesia) morphine bolus demands up to 24 hours.
Measured: 24 hours
Total opioid consumption at 48 hours.
Total opioid consumption at 48 hours - converted to IV morphine equivalents.
Measured: 48 hours
QbsQoR-11.
Quality of Recovery questionnaire.
Measured: 24, 48 hours
QoR-15.
Quality of Recovery questionnaire.
Measured: 24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start30 Oct 2018
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruairi Irwin, Coombe Women and Infants University Hospital
- Investigators
- Terry Tan, Principal investigator, Head of Department of Anaesthesia CWIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695588
- Sponsor's protocol ID
- CWIUH-QLB
- Status last verified
- Jul 2019
- First submitted
- 1 Oct 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section: A Prospective, Double-blind, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03695588
- Acronym / sponsor ID
- CWIUH-QLB
- Conditions
- Quadratus Lumborum Block
- Keywords
- pain relief, Caesarean, Cesarean, c-section, intrathecal morphine, analgesia, QLB, QL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 4 Oct 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.
There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.
Detailed description
Post-operative pain relief management remains challenging after Caesarean-section. The perfect postoperative analgesic regimen is yet to be elucidated, but opioids remain a cornerstone whether they are administered intra-thecally, or systemically or both. Unfortunately, opioids are associated with significant adverse effects such as respiratory depression, post-operative nausea and vomiting (PONV), sedation and pruritus. Therefore, the search for opioid sparing analgesic techniques is important.
The study treatment consists of a quadratus lumborum block (QLB) of either 0.25% Levobupivacaine or a simulated sham QLB after C-section under spinal anaesthesia. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope.
Spinal anaesthesia will be performed in a standardised manner using 10-15mg hyperbaric bupivacaine, 20ug fentanyl and 100ug preservative free morphine. Anaesthetic and surgical management will be conducted as per the usual manner. Diclofenac 100mg suppositories and IV Paracetamol 1g will be administered at the end of surgery. A Morphine PCA will be connected to the patient in the recovery room after the intervention.
The bilateral posterior QLB will be performed after surgery in the supine position in an aseptic manner. The patient will be blinded to the group intervention as the sterile drapes will be left hanging blocking the patient's view of the procedure. The block from the spinal anaesthetic will mean the patient is unaware of the procedure being carried out. A curvilinear ultrasound probe will be used to identify the quadratus lumborum muscle.
Intervention group:
Aseptic, ultrasound guided, bilateral QLB using a posterior approach. This is known as the QLB 2 approach. A maximum volume of 20 ml of 0.25% Levobupivacaine will be administered each side. After the procedure a sterile dressing will be placed on the puncture site.
Placebo group:
The patient will be sterilized, draped and scanned in the same manner as the intervention group, until the target injection point is identified. The operator will use a blunt needle to apply pressure to the skin, (without breaking the skin), for one minute as if they are performing the procedure. This will be performed bilaterally. After the procedure, a sterile dressing will be placed over the pressure area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Active comparator | Procedure: Quadratus lumborum blockBilateral posterior QLB with 20ml 0.25% L-Bupivacaine. |
| Sham QLB | Sham comparator | Procedure: Sham QLBSham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective Caesarean section under spinal anaesthesia.
- Age > 18 years old.
- Singleton pregnancy.
Key exclusion criteria (7 listed)
- Contraindication to spinal or regional anaesthesia.
- Allergy/sensitivity/contraindication to study medications.
- Unable to comprehend visual analogue scale.
- BMI > 40.
- Booking weight <40kg.
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 |
|---|---|---|
| Quadratus lumborum blockUltrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2) | Procedure or surgery | Quadratus lumborum block |
| Sham QLBSham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. | Procedure or surgery | Sham QLB |
Primary outcome
IV PCA Morphine consumption up to 24 hours.
Time frame: 24 hours
Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.
7 secondary outcomes
Pain scores at rest.
Time frame: 6, 12, 24, 48 hours
Pain scores on movement.
Time frame: 6, 12, 24, 48 hours
Nausea and vomiting.
Time frame: 24, 48 hours
IV PCA morphine bolus demands.
Time frame: 24 hours
Total opioid consumption at 48 hours.
Time frame: 48 hours
QbsQoR-11.
Time frame: 24, 48 hours
QoR-15.
Time frame: 24, 48 hours
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 23 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Terry Tan principal investigator
Head of Department of Anaesthesia CWIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block in people with Quadratus Lumborum Block, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
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 3 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 23 Jul 2019. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
IV PCA Morphine consumption up to 24 hours. (time frame: 24 hours). 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 23 Jul 2019.