Intrathecal Morphine, Pain Control, Pediatrics, Ureteral Reimplantation
Conditions
Brief 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. 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.
Interventions
DRUGIntrathecal 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.
DRUGQuadratus 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient and their parent/guardians will be blinded.
Eligibility
Sex/Gender
ALL
Age
12 Months to 11 Years
Healthy volunteers
No
Inclusion criteria
* Ages 12 months to 11 years old * Undergoing an open lower abdominal procedure
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia - Pain Score 0-10 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient/Family Satisfaction | up to 48 hours post-operative | 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). |
| Number of Participants With Side Effects of Each Intervention | up to 48 hours post-operative | The secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis. |
| Total Length of Hospital Stay - Length of Stay, Days | 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. |
| Total Length of PACU Stay - Minutes | 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. |
| Severity of Side Effects With Each Intervention | 0-48 hours post-operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Total | Quadratus Lumborum Block | Intrathecal Morphine |
|---|---|---|---|
| Age, Continuous | 4.607 years STANDARD_DEVIATION 3.089 | 4.4 years STANDARD_DEVIATION 2.8 | 5 years STANDARD_DEVIATION 3.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Procedure Type Enterocystoplasty | 1 Participants | 1 Participants | 0 Participants |
| Procedure Type Laparoscopy | 1 Participants | 1 Participants | 0 Participants |
| Procedure Type Ureteral Reimplantation | 12 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 4 / 5 | 4 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
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.
Time frame: Up to 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrathecal Morphine | Duration of Analgesia - MME/kg in First 24 Hours | 0.03 MME/kg | Standard Deviation 0.06 |
| Quadratus Lumborum Block | Duration of Analgesia - MME/kg in First 24 Hours | 0.08 MME/kg | Standard Deviation 0.13 |
Primary
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.
Time frame: Up to 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrathecal Morphine | Duration of Analgesia - Pain Score 0-10 | 1.0 units on a scale | Standard Deviation 0.8 |
| Quadratus Lumborum Block | Duration of Analgesia - Pain Score 0-10 | 1.5 units on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: up to 48 hours post-operative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intrathecal Morphine | Number of Participants With Side Effects of Each Intervention | Pruritis | 2 Participants |
| Intrathecal Morphine | Number of Participants With Side Effects of Each Intervention | Nausea and/or Vomiting | 4 Participants |
| Quadratus Lumborum Block | Number of Participants With Side Effects of Each Intervention | Pruritis | 2 Participants |
| Quadratus Lumborum Block | Number of Participants With Side Effects of Each Intervention | Nausea and/or Vomiting | 3 Participants |
Secondary
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).
Time frame: up to 48 hours post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intrathecal Morphine | Patient/Family Satisfaction | Satisfaction with pain control | 89.0 units on a scale | Standard Deviation 17.5 |
| Intrathecal Morphine | Patient/Family Satisfaction | Overall satisfaction | 88.0 units on a scale | Standard Deviation 11.5 |
| Quadratus Lumborum Block | Patient/Family Satisfaction | Satisfaction with pain control | 73.3 units on a scale | Standard Deviation 29.6 |
| Quadratus Lumborum Block | Patient/Family Satisfaction | Overall satisfaction | 87.2 units on a scale | Standard Deviation 17.5 |
Secondary
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.
Time frame: 0-48 hours post-operatively
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intrathecal Morphine | Severity of Side Effects With Each Intervention | Pruritus | 65.0 units on a scale | Standard Deviation 21.2 |
| Intrathecal Morphine | Severity of Side Effects With Each Intervention | Nausea and/or Vomiting | 55.0 units on a scale | Standard Deviation 17.3 |
| Quadratus Lumborum Block | Severity of Side Effects With Each Intervention | Pruritus | 30.0 units on a scale | Standard Deviation 28.3 |
| Quadratus Lumborum Block | Severity of Side Effects With Each Intervention | Nausea and/or Vomiting | 60.0 units on a scale | Standard Deviation 10 |
Secondary
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.
Time frame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrathecal Morphine | Total Length of Hospital Stay - Length of Stay, Days | 1.4 days | Standard Deviation 0.6 |
| Quadratus Lumborum Block | Total Length of Hospital Stay - Length of Stay, Days | 2.0 days | Standard Deviation 1.6 |
Secondary
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.
Time frame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrathecal Morphine | Total Length of PACU Stay - Minutes | 42.8 minutes | Standard Deviation 37 |
| Quadratus Lumborum Block | Total Length of PACU Stay - Minutes | 57.4 minutes | Standard Deviation 37 |