Cesarean SectionNCT03267628
Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)
A study testing Intrathecal morphine as well as local anaesthetic in Blocks, Intrathecal morphine as well as saline in Block and Saline intrathecal as well as saline in Blocks in people with Cesarean Section and Pain, Acute, run by Dr Willem Basson.
Trial summary
The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Pain, Acute
- What is being tested?
- Intrathecal morphine as well as local anaesthetic in Blocks, Intrathecal morphine as well as saline in Block and Saline intrathecal as well as saline in Blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anaesthetist trained in QLB and ITM techniques available
- American Society of Anaesthesiologists PS category client I or II
- 18 years of age or older
- Ability to read and understand English
- Uncomplicated pregnancy at term (>37 weeks completed gestation)
- Booked elective CS
Who cannot join
- Contraindications to spinal anaesthesia
- History of chronic opioid consumption / chronic pain conditions
- Known allergy to study drugs
- Weight more than 95kg or body mass index (BMI) more than 35 pre operative
- Placenta Previa / accreta
- Obstructive Sleep apnoea
- Severe asthma unable to tolerate Non steroidal anti inflammatory agents
About this study
Official title: Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.
Read the detailed description
In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.
The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.
In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.
- Conditions
- Cesarean Section, Pain, Acute
- Being tested
- Intrathecal morphine as well as local anaesthetic in Blocks, Intrathecal morphine as well as saline in Block, Saline intrathecal as well as saline in Blocks, Saline intrathecal as well as local anaesthetic in Blocks
- Keywords
- intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine as well as local anaesthetic in BlocksProcedure or surgery
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.
Intrathecal morphine as well as saline in BlockProcedure or surgery
150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
Saline intrathecal as well as saline in BlocksProcedure or surgery
0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
Saline intrathecal as well as local anaesthetic in BlocksProcedure or surgery
0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
| Study group | Role | What they receive |
|---|---|---|
| Saline intrathecal as well as saline in Blocks | Sham comparator | These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. Receives: Procedure: Saline intrathecal as well as saline in Blocks; Procedure: Saline intrathecal as well as local anaesthetic in Blocks |
| Saline intrathecal as well as local anaesthetic in Blocks | Active comparator | These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. Receives: Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Saline intrathecal as well as saline in Blocks |
| Intrathecal morphine as well as local anaesthetic in Blocks | Active comparator | These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. Receives: Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Intrathecal morphine as well as saline in Block |
| Intrathecal morphine as well as saline in Block | Active comparator | These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. Receives: Procedure: Intrathecal morphine as well as saline in Block; Procedure: Saline intrathecal as well as local anaesthetic in Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours total intravenous morphine usage via a PCA pump
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
Measured: 24 hours
Secondary outcomes (2)
Patient's side effects within the 24 hours post operative period.
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
Measured: 24 hours
Pain Scores within 24 hours post operative period.
Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
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 posted30 Aug 2017
- Study start1 Jan 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: We at the Sunshine Coast University Hospital are unable to cope with the extra effort/time needed to complete this trial properly.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Willem Basson
- Sponsor type
- University, hospital or other
- Collaborators
- Sunshine Coast Hospital and Health Service
- Responsible party
- Sponsor-investigator, Dr Willem Basson, Sunshine Coast Hospital and Health Service
- Investigators
- Willem Basson, FANZCA, Principal investigator, Sunshine Coast University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267628
- Sponsor's protocol ID
- HREC/17/QPCH/121
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2017
- Last updated
- 17 Apr 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
- ClinicalTrials.gov ID
- NCT03267628
- Acronym / sponsor ID
- HREC/17/QPCH/121
- Conditions
- Cesarean Section, Pain, Acute
- Keywords
- intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We at the Sunshine Coast University Hospital are unable to cope with the extra effort/time needed to complete this trial properly.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr Willem BassonUniversity, hospital or other
- Collaborators
- Sunshine Coast Hospital and Health Service
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Aug 2017 (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.
The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.
Detailed description
In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.
The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.
In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.
| Arm | Type | Receives |
|---|---|---|
| Saline intrathecal as well as saline in Blocks | Sham comparator | Procedure: Saline intrathecal as well as saline in Blocks, Procedure: Saline intrathecal as well as local anaesthetic in BlocksThese 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. |
| Saline intrathecal as well as local anaesthetic in Blocks | Active comparator | Procedure: Intrathecal morphine as well as local anaesthetic in Blocks, Procedure: Saline intrathecal as well as saline in BlocksThese 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. |
| Intrathecal morphine as well as local anaesthetic in Blocks | Active comparator | Procedure: Intrathecal morphine as well as local anaesthetic in Blocks, Procedure: Intrathecal morphine as well as saline in BlockThese 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. |
| Intrathecal morphine as well as saline in Block | Active comparator | Procedure: Intrathecal morphine as well as saline in Block, Procedure: Saline intrathecal as well as local anaesthetic in BlocksThese 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Anaesthetist trained in QLB and ITM techniques available
- American Society of Anaesthesiologists PS category client I or II
- 18 years of age or older
- Ability to read and understand English
- Uncomplicated pregnancy at term (>37 weeks completed gestation)
Key exclusion criteria (7 listed)
- Contraindications to spinal anaesthesia
- History of chronic opioid consumption / chronic pain conditions
- Known allergy to study drugs
- Weight more than 95kg or body mass index (BMI) more than 35 pre operative
- Placenta Previa / accreta
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 as well as local anaesthetic in BlocksA Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic. | Procedure or surgery | Intrathecal morphine as well as local anaesthetic in Blocks, Saline intrathecal as well as local anaesthetic in Blocks |
| Intrathecal morphine as well as saline in Block150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block. | Procedure or surgery | Intrathecal morphine as well as local anaesthetic in Blocks, Intrathecal morphine as well as saline in Block |
| Saline intrathecal as well as saline in Blocks0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block. | Procedure or surgery | Saline intrathecal as well as local anaesthetic in Blocks, Saline intrathecal as well as saline in Blocks |
| Saline intrathecal as well as local anaesthetic in Blocks0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. | Procedure or surgery | Intrathecal morphine as well as saline in Block, Saline intrathecal as well as saline in Blocks |
Primary outcome
24 hours total intravenous morphine usage via a PCA pump
Time frame: 24 hours
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
2 secondary outcomes
Patient's side effects within the 24 hours post operative period.
Time frame: 24 hours
Pain Scores within 24 hours post operative period.
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 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.
Willem Basson, FANZCA principal investigator
Sunshine Coast University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine as well as local anaesthetic in Blocks, Intrathecal morphine as well as saline in Block and Saline intrathecal as well as saline in Blocks in people with Cesarean Section and Pain, Acute, run by Dr Willem Basson.
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 6 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: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
24 hours total intravenous morphine usage via a PCA pump (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 17 Apr 2019.