Trial Outcomes & Findings for ITM vs QL for Pediatric Open Lower Abdominal Procedures (NCT NCT05506930)
NCT ID: NCT05506930
Last Updated: 2025-04-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Up to 24 hours post-op
Results posted on
2025-04-15
Participant Flow
Participant milestones
| Measure |
Intrathecal Morphine
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ITM vs QL for Pediatric Open Lower Abdominal Procedures
Baseline characteristics by cohort
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
Total
n=14 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
5 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
4.4 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
4.607 years
STANDARD_DEVIATION 3.089 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Procedure Type
Laparoscopy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Procedure Type
Ureteral Reimplantation
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Procedure Type
Enterocystoplasty
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-opThe 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.
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
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|---|---|---|
|
Duration of Analgesia - Pain Score 0-10
|
1.0 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Up to 24 hours post-opThe 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.
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Duration of Analgesia - MME/kg in First 24 Hours
|
0.03 MME/kg
Standard Deviation 0.06
|
0.08 MME/kg
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: up to 48 hours post-operativeThe secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis.
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
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|---|---|---|
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Number of Participants With Side Effects of Each Intervention
Pruritis
|
2 Participants
|
2 Participants
|
|
Number of Participants With Side Effects of Each Intervention
Nausea and/or Vomiting
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 0-48 hours post-operativelyPopulation: Patients may have experienced one side effect or both, therefore there may be overlap in participant numbers reporting a score. Four unique participants in the intrathecal morphine group reported 6 instances of side effects, and 4 subjects in the QL group reported 5 instances of size effects.
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.
Outcome measures
| Measure |
Intrathecal Morphine
n=4 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=4 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
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|---|---|---|
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Severity of Side Effects With Each Intervention
Pruritus
|
65.0 units on a scale
Standard Deviation 21.2
|
30.0 units on a scale
Standard Deviation 28.3
|
|
Severity of Side Effects With Each Intervention
Nausea and/or Vomiting
|
55.0 units on a scale
Standard Deviation 17.3
|
60.0 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: up to 48 hours post-operativeThis 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).
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Patient/Family Satisfaction
Overall satisfaction
|
88.0 units on a scale
Standard Deviation 11.5
|
87.2 units on a scale
Standard Deviation 17.5
|
|
Patient/Family Satisfaction
Satisfaction with pain control
|
89.0 units on a scale
Standard Deviation 17.5
|
73.3 units on a scale
Standard Deviation 29.6
|
SECONDARY outcome
Timeframe: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)This endpoint will assess how long the patient's PACU stay was in minutes. The longer the stay, the worse the outcome.
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Total Length of PACU Stay - Minutes
|
42.8 minutes
Standard Deviation 37.0
|
57.4 minutes
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 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.
Outcome measures
| Measure |
Intrathecal Morphine
n=5 Participants
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 Participants
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Total Length of Hospital Stay - Length of Stay, Days
|
1.4 days
Standard Deviation 0.6
|
2.0 days
Standard Deviation 1.6
|
Adverse Events
Intrathecal Morphine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Quadratus Lumborum Block
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intrathecal Morphine
n=5 participants at risk
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
Intrathecal Morphine: 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 Block
n=9 participants at risk
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
Quadratus lumborum block: 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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and/or Vomiting
|
80.0%
4/5 • Number of events 4 • Adverse events were collected from 0-48 hours post-operatively through in-person assessments and chart review.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from 0-48 hours post-operatively through in-person assessments and chart review.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5 • Number of events 2 • Adverse events were collected from 0-48 hours post-operatively through in-person assessments and chart review.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from 0-48 hours post-operatively through in-person assessments and chart review.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place