Pain ControlPhase 4NCT05506930
ITM vs QL for Pediatric Open Lower Abdominal Procedures
A Phase 4 study testing Intrathecal Morphine and Quadratus lumborum block in people with Pain Control and Ureteral Reimplantation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. Read more about this study
- Who is it for?
- Ages 12 months to 11 years
- Conditions the study is for
- Pain Control, Ureteral Reimplantation, Pediatrics
- What is being tested?
- Intrathecal Morphine and Quadratus lumborum block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 10 May 2024
- Phase
- Phase 4
- 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 12 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 12 months to 11 years old
- Undergoing an open lower abdominal procedure
Who cannot join
- Allergy to morphine or amide local anesthetics
- Localized rash at site of planned regional anesthetic block
- Bleeding diathesis
- Spinal dysmorphism
- Previous spinal surgery with instrumentation of the lumbar spine
- Inability or unwillingness of parent or legal guardian to give informed consent.
- Prior enrollment and randomization in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
- Being tested
- Intrathecal Morphine, Quadratus lumborum block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called ITM
One group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist while the subject is already under general anesthesia. This procedure is well-described in the pediatric population and used regularly for postoperative pain relief for a variety of procedures including ureteral reimplantation.
Quadratus lumborum blockDrug
Also called QL
The second group of subjects will have bilateral quadratus lumborum blocks: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per side (total dose approximately 1mL/kg). This is injected in the subject's flank in the fascial plane between the quadratus lumborum muscle and the psoas muscle. Ultrasound guidance is used for needle and structure localization and this procedure is done by a pediatric anesthesiologist while the subject is already under general anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for postoperative pain relief for a variety of abdominal procedures.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Active comparator | Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg Receives: Drug: Intrathecal Morphine |
| quadratus lumborum block | Active comparator | Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg). Receives: Drug: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia - Pain Score 0-10
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by charted pain scores in the first 24 hours. Pain scores were collected from the medical record on a scale from 0-10; the higher the score, the worse the outcome/pain. Time points in the 24 hours post op for each patient varied based on nursing care as the data was collected from the medical record.
Measured: Up to 24 hours post-op
Duration of Analgesia - MME/kg in First 24 Hours
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by morphine milligram equivalents (MME)/kg in the first 24 hours. The higher the MME/kg, the worse the pain.
Measured: Up to 24 hours post-op
Secondary outcomes (5)
Number of Participants With Side Effects of Each Intervention
The secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis.
Measured: up to 48 hours post-operative
Severity of Side Effects With Each Intervention
The secondary endpoint assesses the severity of side effects with each intervention such as nausea and/or vomiting, and pruritus in the patients who experienced a side effect. Parents of participants who experienced the side effects listed rated the severity of them using a Visual Analog Scale from 0-100mm. The higher the score, the worse the side effect.
Measured: 0-48 hours post-operatively
Patient/Family Satisfaction
This endpoint will assess patient and family overall satisfaction with their child's pain control and experience of their child's post-op recovery. Satisfaction will be rated using VAS 0 (not satisfied) to 100 (completely satisfied).
Measured: up to 48 hours post-operative
Total Length of PACU Stay - Minutes
This endpoint will assess how long the patient's PACU stay was in minutes. The longer the stay, the worse the outcome.
Measured: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
Total Length of Hospital Stay - Length of Stay, Days
This endpoint will assess how long the patient's hospital stay was overall in days. The higher the number of days, the worse the outcome.
Measured: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start17 Aug 2022
- Primary completion9 May 2024
- Study completion10 May 2024
Why it stopped: The study was stopped early based on the anecdotal evidence from a surgeon who felt one group was experiencing more side effects than the other. Exposing pediatric patients who would be assigned to the inferior arm was difficult to justify ethically.
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 ControlStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Barnett, Medical University of South Carolina
- Investigators
- Natalie Barnett, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506930
- Sponsor's protocol ID
- Pro00121082
- Status last verified
- Apr 2025
- First submitted
- 12 Aug 2022
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05506930
- Acronym / sponsor ID
- Pro00121082
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early based on the anecdotal evidence from a surgeon who felt one group was experiencing more side effects than the other. Exposing pediatric patients who would be assigned to the inferior arm was difficult to justify ethically.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Active comparator | Drug: Intrathecal MorphineIntrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg |
| quadratus lumborum block | Active comparator | Drug: Quadratus lumborum blockQuadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg). |
Who may qualify
- Ages
- 12 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages 12 months to 11 years old
- Undergoing an open lower abdominal procedure
Key exclusion criteria (7 listed)
- Allergy to morphine or amide local anesthetics
- Localized rash at site of planned regional anesthetic block
- Bleeding diathesis
- Spinal dysmorphism
- Previous spinal surgery with instrumentation of the lumbar spine
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 MorphineAlso: ITMOne group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist while the subject is already under general anesthesia. This procedure is well-described in the pediatric population and used regularly for postoperative pain relief for a variety of procedures including ureteral reimplantation. | Drug | Intrathecal Morphine |
| Quadratus lumborum blockAlso: QLThe second group of subjects will have bilateral quadratus lumborum blocks: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per side (total dose approximately 1mL/kg). This is injected in the subject's flank in the fascial plane between the quadratus lumborum muscle and the psoas muscle. Ultrasound guidance is used for needle and structure localization and this procedure is done by a pediatric anesthesiologist while the subject is already under general anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for postoperative pain relief for a variety of abdominal procedures. | Drug | quadratus lumborum block |
Primary outcome
Duration of Analgesia - Pain Score 0-10
Time frame: Up to 24 hours post-op
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by charted pain scores in the first 24 hours. Pain scores were collected from the medical record on a scale from 0-10; the higher the score, the worse the outcome/pain. Time points in the 24 hours post op for each patient varied based on nursing care as the data was collected from the medical record.
Duration of Analgesia - MME/kg in First 24 Hours
Time frame: Up to 24 hours post-op
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by morphine milligram equivalents (MME)/kg in the first 24 hours. The higher the MME/kg, the worse the pain.
5 secondary outcomes
Number of Participants With Side Effects of Each Intervention
Time frame: up to 48 hours post-operative
Severity of Side Effects With Each Intervention
Time frame: 0-48 hours post-operatively
Patient/Family Satisfaction
Time frame: up to 48 hours post-operative
Total Length of PACU Stay - Minutes
Time frame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
Total Length of Hospital Stay - Length of Stay, Days
Time frame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Natalie Barnett, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal Morphine and Quadratus lumborum block in people with Pain Control and Ureteral Reimplantation, run by Medical University of South Carolina 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 2 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 15 Apr 2025. 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. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2025). 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?
Duration of Analgesia - Pain Score 0-10 (time frame: Up to 24 hours post-op). The study lists 2 primary outcomes in all. 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 15 Apr 2025.