Trial Outcomes & Findings for QL Block With Exparel in Colectomy (NCT NCT03827291)
NCT ID: NCT03827291
Last Updated: 2025-10-16
Results Overview
Measured in morphine milligram equivalents.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
From arrival to PACU to 48 hours post-operatively
Results posted on
2025-10-16
Participant Flow
Historical Controls were not considered enrolled in this study.
Participant milestones
| Measure |
Quadratus Lumborum Block
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL (quadratus lumborum) and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Quadratus Lumborum Block
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL (quadratus lumborum) and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Overall Study
Intraoperative conversion of surgery from laparoscopic to open
|
5
|
0
|
Baseline Characteristics
QL Block With Exparel in Colectomy
Baseline characteristics by cohort
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From arrival to PACU to 48 hours post-operativelyMeasured in morphine milligram equivalents.
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Cumulative Opioid Consumption Over 48 Hours
|
33 morphine milligram equivalents
Interval 8.0 to 76.0
|
61 morphine milligram equivalents
Interval 40.0 to 85.0
|
SECONDARY outcome
Timeframe: 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administrationPopulation: Data not collected at 144 hours or 168 hours.
The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain.
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
30 minutes
|
5 score on a scale
Interval 3.0 to 7.0
|
4 score on a scale
Interval 0.0 to 7.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
8 hours
|
3 score on a scale
Interval 2.0 to 6.0
|
0 score on a scale
Interval 0.0 to 3.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
24 hours
|
3 score on a scale
Interval 2.0 to 4.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
36 hours
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
48 hours
|
4 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 0.0 to 7.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
72 hours
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 0.0 to 6.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
96 hours
|
2 score on a scale
Interval 0.0 to 5.0
|
5 score on a scale
Interval 3.0 to 6.0
|
|
Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)
120 hours
|
2 score on a scale
Interval 1.0 to 5.0
|
5 score on a scale
Interval 2.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administrationPresence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively.
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Number of Participants With Block Success
|
7 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From administration of Exparel through 168 hours post Exparel administrationSubjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Number of Participants With Adverse Events Related to the Block
|
6 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 48 hours post Exparel administrationPopulation: Not applicable to the historical thoracic epidural analgesia group.
Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied.
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Satisfaction With Postoperative Pain Control
|
8 score on a scale
Interval 3.0 to 9.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From administration of Exparel through hospital dischargeMeasured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Hospital Length of Stay
|
27 hours
Interval 24.0 to 46.0
|
55 hours
Interval 52.0 to 97.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From administration of Exparel through 168 hours post Exparel administrationAdverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression.
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Number of Participants With Opioid-related Adverse Events
|
10 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From time of arrival in PACU through first mobilizationOutcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 Participants
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Time to First Mobilization
|
15 hours
Interval 8.0 to 19.0
|
31 hours
Interval 27.0 to 49.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From time of arrival in PACU through 96 hours post Exparel administrationPopulation: Data not collected.
Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 168 hours post Exparel administrationPopulation: Not applicable to the historical thoracic epidural analgesia group.
Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: "How much did pain interfere with falling asleep?", "How much did pain interfere with staying asleep?"
Outcome measures
| Measure |
Quadratus Lumborum Block
n=30 Participants
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Sleep Quality as Measured by Two Questions
|
4 score on a scale
Interval 2.0 to 8.0
|
—
|
Adverse Events
Quadratus Lumborum Block
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Thoracic Epidural Analgesia
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quadratus Lumborum Block
n=30 participants at risk
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 participants at risk
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Nervous system disorders
Extended hospital stay due to left lower extremity numbness
|
3.3%
1/30 • From arrival to PACU to postoperative day 7
|
0.00%
0/30 • From arrival to PACU to postoperative day 7
|
Other adverse events
| Measure |
Quadratus Lumborum Block
n=30 participants at risk
Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
|
Thoracic Epidural Analgesia
n=30 participants at risk
Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
0.00%
0/30 • From arrival to PACU to postoperative day 7
|
26.7%
8/30 • From arrival to PACU to postoperative day 7
|
|
Cardiac disorders
Orthostasis
|
10.0%
3/30 • From arrival to PACU to postoperative day 7
|
26.7%
8/30 • From arrival to PACU to postoperative day 7
|
|
Nervous system disorders
Pruritis
|
3.3%
1/30 • From arrival to PACU to postoperative day 7
|
20.0%
6/30 • From arrival to PACU to postoperative day 7
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • From arrival to PACU to postoperative day 7
|
13.3%
4/30 • From arrival to PACU to postoperative day 7
|
|
Nervous system disorders
Unexpected sensory deficit
|
20.0%
6/30 • From arrival to PACU to postoperative day 7
|
10.0%
3/30 • From arrival to PACU to postoperative day 7
|
|
Nervous system disorders
Hip flexor weakness
|
13.3%
4/30 • From arrival to PACU to postoperative day 7
|
10.0%
3/30 • From arrival to PACU to postoperative day 7
|
|
Gastrointestinal disorders
Nausea
|
33.3%
10/30 • From arrival to PACU to postoperative day 7
|
63.3%
19/30 • From arrival to PACU to postoperative day 7
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • From arrival to PACU to postoperative day 7
|
26.7%
8/30 • From arrival to PACU to postoperative day 7
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • From arrival to PACU to postoperative day 7
|
6.7%
2/30 • From arrival to PACU to postoperative day 7
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • From arrival to PACU to postoperative day 7
|
13.3%
4/30 • From arrival to PACU to postoperative day 7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/30 • From arrival to PACU to postoperative day 7
|
3.3%
1/30 • From arrival to PACU to postoperative day 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place