Pain, PostoperativePhase 3qlcsectionNCT03261193
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
A Phase 3 study testing ITM + Bupivacaine QLB in people with Pain, Postoperative, run by Nicholas Schott at 1 site in United States.
Trial summary
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ITM + Bupivacaine QLB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 11 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 planned under spinal anesthesia
- Singleton pregnancy
- American Society of Anesthesiologists (ASA) classification score of 2 (or less)
- Gestational age of at least 37 weeks
- Intention to breastfeed infant
Who cannot join
- Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
- Anatomical abnormalities contraindicating spinal or QLB placement
- Received/Conversion to general anesthesia
- Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
- History of chronic pain
- History of chronic opioid use/abuse
- History of Subutex, methadone, other maintenance therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: QL Block for Post-cesarean Delivery Pain
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
Read the detailed description
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.
Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).
Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.
For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.
The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).
The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.
- Conditions
- Pain, Postoperative
- Being tested
- ITM + Sham QLB, ITM + Bupivacaine QLB
- Keywords
- quadratus lumborum block, post-operative pain, cesarean section pain, analgesia, nerve block
- 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.
ITM + Sham QLBDrug
Also called Saline
Sham subcutaneous non-anesthetic infiltration with saline
ITM + Bupivacaine QLBDrug
Also called Bupivacaine
QL plane block with local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ITM + Sham QLB | Sham comparator | Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. Receives: Drug: ITM + Sham QLB |
| ITM + Bupivacaine QLB | Experimental | Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. Receives: Drug: ITM + Bupivacaine QLB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Pain Score With Movement
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Measured: 24 hours after surgical procedure (cesarean delivery)
Secondary outcomes (26)
Breast Feeding Success/Quality
Limited breastfeeding resulting from pain or opioid side effects
Measured: 24-hours post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Measured: 1 hour after intervention
First Request for Pain Medication
Time to first opioid dose (measured in hours)
Measured: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
Sedation
Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
Measured: 24-hours post-operative
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Measured: 4-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Measured: 4-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 4-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Measured: 4-hours post-operative
Oxygen Saturation
Will be measured in % per standard of care and documented by study staff
Measured: 4-hours post-operative
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Measured: 4 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Measured: 24 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Measured: 48 hours after intervention
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Measured: 24-hours post-operative
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Measured: 48-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Measured: 24-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Measured: 48-hours post-operative
Heart Rate
Standard heart rate obtained
Measured: 4-hours post-operative
Heart Rate
Standard heart rate obtained
Measured: 24-hours post-operative
Heart Rate
Standard heart rate obtained
Measured: 48-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 24-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 48-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 4-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 24-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Measured: 48-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Measured: 24-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Measured: 48-hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start5 Sep 2017
- Primary completion25 Jun 2018
- Study completion11 Nov 2022
Why it stopped: limited resources for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas Schott
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Schott, University of Pittsburgh
- Investigators
- Amy Monroe, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261193
- Sponsor's protocol ID
- PRO16120234
- Acronym
- qlcsection
- Status last verified
- May 2024
- First submitted
- 27 Jul 2017
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QL Block for Post-cesarean Delivery Pain
- ClinicalTrials.gov ID
- NCT03261193
- Acronym / sponsor ID
- qlcsection / PRO16120234
- Conditions
- Pain, Postoperative
- Keywords
- quadratus lumborum block, post-operative pain, cesarean section pain, analgesia, nerve block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited resources for recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nicholas SchottUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
Detailed description
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.
Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).
Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.
For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.
The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).
The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITM + Sham QLB | Sham comparator | Drug: ITM + Sham QLBStandard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. |
| ITM + Bupivacaine QLB | Experimental | Drug: ITM + Bupivacaine QLBStandard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Elective cesarean planned under spinal anesthesia
- Singleton pregnancy
- American Society of Anesthesiologists (ASA) classification score of 2 (or less)
- Gestational age of at least 37 weeks
- Intention to breastfeed infant
Key exclusion criteria (7 listed)
- Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
- Anatomical abnormalities contraindicating spinal or QLB placement
- Received/Conversion to general anesthesia
- Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
- History of chronic pain
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 |
|---|---|---|
| ITM + Sham QLBAlso: SalineSham subcutaneous non-anesthetic infiltration with saline | Drug | ITM + Sham QLB |
| ITM + Bupivacaine QLBAlso: BupivacaineQL plane block with local anesthesia | Drug | ITM + Bupivacaine QLB |
Primary outcome
Visual Analogue Scale (VAS) Pain Score With Movement
Time frame: 24 hours after surgical procedure (cesarean delivery)
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
26 secondary outcomes
Breast Feeding Success/Quality
Time frame: 24-hours post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: 1 hour after intervention
First Request for Pain Medication
Time frame: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
Sedation
Time frame: 24-hours post-operative
Pruritis
Time frame: 4-hours post-operative
Nausea/Vomiting
Time frame: 4-hours post-operative
Systolic Blood Pressure
Time frame: 4-hours post-operative
Respiratory Rate
Time frame: 4-hours post-operative
Oxygen Saturation
Time frame: 4-hours post-operative
Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: 4 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: 24 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
Time frame: 48 hours after intervention
Pruritis
Time frame: 24-hours post-operative
Pruritis
Time frame: 48-hours post-operative
Nausea/Vomiting
Time frame: 24-hours post-operative
Nausea/Vomiting
Time frame: 48-hours post-operative
Heart Rate
Time frame: 4-hours post-operative
Heart Rate
Time frame: 24-hours post-operative
Heart Rate
Time frame: 48-hours post-operative
Systolic Blood Pressure
Time frame: 24-hours post-operative
Systolic Blood Pressure
Time frame: 48-hours post-operative
Diastolic Blood Pressure
Time frame: 4-hours post-operative
Diastolic Blood Pressure
Time frame: 24-hours post-operative
Diastolic Blood Pressure
Time frame: 48-hours post-operative
Respiratory Rate
Time frame: 24-hours post-operative
Respiratory Rate
Time frame: 48-hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plans to share
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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.
Amy Monroe study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITM + Bupivacaine QLB in people with Pain, Postoperative, run by Nicholas Schott at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 6 May 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale (VAS) Pain Score With Movement (time frame: 24 hours after surgical procedure (cesarean delivery)). 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 6 May 2024.