Postoperative PainNCT02339766
Quadratus Lumborum Block for Post-Cesarean Analgesia
A study testing Quadratus Lumborum Block, Intrathecal Morphine and Intrathecal Saline in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Most women having planned cesarean section receive spinal anesthetic for the procedure. Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quadratus Lumborum Block, Intrathecal Morphine and Intrathecal Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2015to 5 Feb 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Elective cesarean delivery
- American Society of Anesthesiologists Physical Status 1-3
- Suitable for procedure to be carried out under spinal anesthesia
Who cannot join
- Inability to give informed consent or to co-operate with post-operative evaluation
- Allergy to local anesthetics, morphine, fentanyl, ropivacaine
- Ongoing major medical or psychiatric problems
- Chronic opioid use
- Major coagulopathy
- BMI>35 on first ante natal visit
- Pre-eclampsia
- Contraindication to neuraxial anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
Most women having planned cesarean section receive spinal anesthetic for the procedure.
Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression.
Read more
The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section.
If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block.
We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.
Read the detailed description
This will be a randomized controlled double blinded trial.
Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study.
After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group).
Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture.
Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side.
All patients will receive routine postoperative analgesia, including analgesics and oral morphine.
All patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.
- Conditions
- Postoperative Pain
- Being tested
- Quadratus Lumborum Block, Sham Block, Intrathecal Morphine, Intrathecal Saline
- Keywords
- Cesarean, Quadratus Lumborum Block, Analgesia, Ultrasonography
- Medical subject headings
- Pain, Postoperative, 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
Quadratus Lumborum Block with Ropivacaine 0.5% will be done.
Sham BlockProcedure or surgery
Sham block of Quadratus Lumborum will be done with Saline.
Intrathecal MorphineDrug
Also called Spinal Morphine
Intrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic.
Intrathecal SalineDrug
Also called Placebo
Intrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sham comparator | Group 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side. Receives: Procedure: Sham Block; Drug: Intrathecal Morphine |
| Group 2 | Active comparator | Group 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side. Receives: Procedure: Quadratus Lumborum Block; Drug: Intrathecal Saline |
| Group 3 | Active comparator | Group 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side. Receives: Procedure: Quadratus Lumborum Block; Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on movement at 12 hrs after surgery
Numeric Rating Scale to evaluate pain scores at 12 h after surgery.
Measured: 12 hours
Secondary outcomes (4)
Pain and Morphine consumption at 6,12 24 hrs after surgery.
Numeric Rating Scale to evaluate pain scores.
Measured: 24 hours
Nausea at 6, 12, 24 hrs after surgery
Nausea will be evaluated according to intensity. 0= no nausea; 1= nausea not requiring pharmacologic treatment; 2= nausea requiring pharmacologic treatment.
Measured: 24 hours
Chronic Wound Pain at 6 weeks
Development of chronic pain around incisional wound will be evaluated by phone interview.
Measured: 6 weeks
Pruritus at 6, 12, 24 hrs after surgery
Pruritus will be evaluated according to intensity 0= no pruritus; 1= pruritus not requiring pharmacologic treatment; 2= pruritus requiring pharmacologic treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study start1 Oct 2015
- Primary completion5 Feb 2017
- Study completion5 Feb 2017
Why it stopped: Not feasible due to difficulty with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalini Dhir, MD, FRCPC, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339766
- Sponsor's protocol ID
- 106224
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2015
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Morphine With Quadratus Lumborum Block for Post-Cesarean Delivery Analgesia:
- ClinicalTrials.gov ID
- NCT02339766
- Acronym / sponsor ID
- 106224
- Conditions
- Postoperative Pain
- Keywords
- Cesarean, Quadratus Lumborum Block, Analgesia, Ultrasonography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not feasible due to difficulty with recruitment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 5 Feb 2017 (actual)
- Study completion
- 5 Feb 2017 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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.
Most women having planned cesarean section receive spinal anesthetic for the procedure.
Typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. However, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression.
The quadratus lumborum (QL) block is a regional analgesic technique which blocks T5-L1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. There is some evidence that it may provide visceral along with somatic pain relief. It is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section.
If found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. This block has evolved from the previously known transversus abdominis plane block.
We propose to undertake a study that will compare the relative efficacy of QL block with local anesthetic to spinal morphine. We will also study if it provides any incremental benefit when administered in addition to spinal morphine.
Detailed description
This will be a randomized controlled double blinded trial.
Seventy five female patients belonging to American Society of Anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study.
After obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. All patients will receive standard spinal anesthetic. They will be randomized to one of the three groups (n=25 per group).
Groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. Group 2 will receive equal volume of saline added to the intrathecal mixture.
Ultrasound guided Quadratus Lumborum block will be done. Following negative aspiration, 25 mL of Ropivacaine 0.5% (Groups 2 and 3), or the same amount of saline (Group 1) will be injected in each side.
All patients will receive routine postoperative analgesia, including analgesics and oral morphine.
All patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Sham comparator | Procedure: Sham Block, Drug: Intrathecal MorphineGroup 1 will receive intrathecal morphine co-administered with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Sham Block be done with 25 mL of saline per side. |
| Group 2 | Active comparator | Procedure: Quadratus Lumborum Block, Drug: Intrathecal SalineGroup 2 will receive an equivalent volume of intrathecal saline co-administered with the spinal anesthetic. After surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side. |
| Group 3 | Active comparator | Procedure: Quadratus Lumborum Block, Drug: Intrathecal MorphineGroup 3 will receive will receive intrathecal morphine with the spinal anesthetic. After the completion of surgery, bilateral ultrasound guided Quadratus Lumborum Block will be performed with 25 ml 0.5% Ropivacaine per side. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective cesarean delivery
- American Society of Anesthesiologists Physical Status 1-3
- Suitable for procedure to be carried out under spinal anesthesia
Key exclusion criteria (8 listed)
- Inability to give informed consent or to co-operate with post-operative evaluation
- Allergy to local anesthetics, morphine, fentanyl, ropivacaine
- Ongoing major medical or psychiatric problems
- Chronic opioid use
- Major coagulopathy
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 BlockQuadratus Lumborum Block with Ropivacaine 0.5% will be done. | Procedure or surgery | Group 2, Group 3 |
| Sham BlockSham block of Quadratus Lumborum will be done with Saline. | Procedure or surgery | Group 1 |
| Intrathecal MorphineAlso: Spinal MorphineIntrathecal Morphine 150 mcg will be co-administered with the spinal anesthetic. | Drug | Group 1, Group 3 |
| Intrathecal SalineAlso: PlaceboIntrathecal Saline 0.15 mL will be co-administered with the spinal anesthetic. | Drug | Group 2 |
Primary outcome
Pain on movement at 12 hrs after surgery
Time frame: 12 hours
Numeric Rating Scale to evaluate pain scores at 12 h after surgery.
4 secondary outcomes
Pain and Morphine consumption at 6,12 24 hrs after surgery.
Time frame: 24 hours
Nausea at 6, 12, 24 hrs after surgery
Time frame: 24 hours
Chronic Wound Pain at 6 weeks
Time frame: 6 weeks
Pruritus at 6, 12, 24 hrs after surgery
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Not feasible due to difficulty with recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- 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.
Shalini Dhir, MD, FRCPC principal investigator
University of Western Ontario, Canada
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, Intrathecal Morphine and Intrathecal Saline in people with Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 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: stopped early, as of the sponsor's last update on 22 Oct 2021. 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 Canada. 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 was stopped early (reason given: Not feasible due to difficulty with recruitment.). Results are not available in the source record.
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?
Pain on movement at 12 hrs after surgery (time frame: 12 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 22 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.