Conditions Requiring Colorectal Surgery
Conditions
Brief summary
This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.
Detailed description
Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT). Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.
Interventions
DRUGEXPAREL
transversus abdominis plane injection
Intrathecal opioid administration
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT * Age \>18 years * BMI \<40 * Ability to understand and read English
Exclusion criteria
* • Not able or unwilling to sign consent. * Currently pregnant or lactating. * Patients with chronic pain, requiring daily opiate use at time of surgery. * Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics. * Patients requiring emergent surgery. * Abdominoperineal resections * Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology) * Patients with a diagnosis of inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | First 48 hours post operative | Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation. |
| Total Morphine Milligram Equivalents Use (MME) | First 48 hours post operative | The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Hospital Stay | post-operative to discharge | Length of stay was defined as the total number of nights spent in the hospital after surgery. |
| Number of Participants With Post-operative Ileus | 24 hours post-operatively | Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery. |
| Use of Intravenous Patient-controlled Analgesia | First 48 hours post-operative | The total number of patients that used patient-controlled analgesia within 48 hours after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAP Block (EXPAREL) After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline.
EXPAREL: transversus abdominis plane injection | 102 |
| Intrathecal Opioid (IT) single injection intrathecal hydromorphone analgesia given preoperatively
Intrathecal hydromorphone: Intrathecal opioid administration | 98 |
| Total | 200 |
Baseline characteristics
| Characteristic | Intrathecal Opioid (IT) | Total | TAP Block (EXPAREL) |
|---|---|---|---|
| Age, Continuous | 58 years | 60 years | 61 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 98 participants | 200 participants | 102 participants |
| Sex: Female, Male Female | 43 Participants | 88 Participants | 45 Participants |
| Sex: Female, Male Male | 55 Participants | 112 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 98 |
| other Total, other adverse events | 0 / 102 | 0 / 98 |
| serious Total, serious adverse events | 4 / 102 | 4 / 98 |
Outcome results
Primary
Mean Pain Score
Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.
Time frame: First 48 hours post operative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block (EXPAREL) | Mean Pain Score | 3.0 score on a scale |
| Intrathecal Opioid (IT) | Mean Pain Score | 2.4 score on a scale |
p-value: 0.007t-test, 2 sided
Primary
Total Morphine Milligram Equivalents Use (MME)
The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.
Time frame: First 48 hours post operative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP Block (EXPAREL) | Total Morphine Milligram Equivalents Use (MME) | 47.5 total morphine milligram equivalents |
| Intrathecal Opioid (IT) | Total Morphine Milligram Equivalents Use (MME) | 32.5 total morphine milligram equivalents |
p-value: 0.102Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Post-operative Ileus
Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.
Time frame: 24 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block (EXPAREL) | Number of Participants With Post-operative Ileus | 11 Participants |
| Intrathecal Opioid (IT) | Number of Participants With Post-operative Ileus | 14 Participants |
p-value: 0.454Chi-squared
Secondary
Total Length of Hospital Stay
Length of stay was defined as the total number of nights spent in the hospital after surgery.
Time frame: post-operative to discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAP Block (EXPAREL) | Total Length of Hospital Stay | 3 nights |
| Intrathecal Opioid (IT) | Total Length of Hospital Stay | 3 nights |
p-value: 0.85Wilcoxon (Mann-Whitney)
Secondary
Use of Intravenous Patient-controlled Analgesia
The total number of patients that used patient-controlled analgesia within 48 hours after surgery.
Time frame: First 48 hours post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block (EXPAREL) | Use of Intravenous Patient-controlled Analgesia | 5 Participants |
| Intrathecal Opioid (IT) | Use of Intravenous Patient-controlled Analgesia | 1 Participants |
p-value: 0.212Fisher Exact