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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP block (EXPAREL) | Active Comparator | 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. |
|
| Intrathecal opioid (IT) | Active Comparator | single injection intrathecal hydromorphone analgesia given preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL | Drug | transversus abdominis plane injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 48 hours post operative |
| 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. | First 48 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Total Length of Hospital Stay | Length of stay was defined as the total number of nights spent in the hospital after surgery. | post-operative to discharge |
| Number of Participants With Post-operative Ileus |
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Inclusion Criteria:
• All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT
Exclusion Criteria:
• Not able or unwilling to sign consent.
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| Name | Affiliation | Role |
|---|---|---|
| Dorin Colibaseanu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30919948 | Derived | Colibaseanu DT, Osagiede O, Merchea A, Ball CT, Bojaxhi E, Panchamia JK, Jacob AK, Kelley SR, Naessens JM, Larson DW. Randomized clinical trial of liposomal bupivacaine transverse abdominis plane block versus intrathecal analgesia in colorectal surgery. Br J Surg. 2019 May;106(6):692-699. doi: 10.1002/bjs.11141. Epub 2019 Mar 28. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Intrathecal Opioid (IT) | single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | First 48 hours post operative |
|
The study treatment follow-up period was defined as 30 days +/- 10 days following the last administration of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal wound infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dorin T. Colibaseanu, MD | Mayo Clinic | 904-953-2596 | colibaseanu.dorin@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2017 | Jan 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Intrathecal hydromorphone | Drug | Intrathecal opioid administration |
|
|
Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.
| 24 hours post-operatively |
| Use of Intravenous Patient-controlled Analgesia | The total number of patients that used patient-controlled analgesia within 48 hours after surgery. | First 48 hours post-operative |
| Intrathecal Opioid (IT) |
single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration |
|
|
|
| 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. | Posted | Median | 95% Confidence Interval | total morphine milligram equivalents | First 48 hours post operative |
|
|
|
|
| Secondary | Total Length of Hospital Stay | Length of stay was defined as the total number of nights spent in the hospital after surgery. | Posted | Median | 95% Confidence Interval | nights | post-operative to discharge |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 24 hours post-operatively |
|
|
|
|
| Secondary | Use of Intravenous Patient-controlled Analgesia | The total number of patients that used patient-controlled analgesia within 48 hours after surgery. | Posted | Count of Participants | Participants | First 48 hours post-operative |
|
|
|
|
| 0 |
| 102 |
| 4 |
| 102 |
| 0 |
| 102 |
| EG001 | Intrathecal Opioid (IT) | single injection intrathecal hydromorphone analgesia given preoperatively Intrathecal hydromorphone: Intrathecal opioid administration | 0 | 98 | 4 | 98 | 0 | 98 |
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Spinal fluid leakage | Nervous system disorders | Systematic Assessment |
|
| Bleeding at injection site | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Intra-abdominal abscess | Gastrointestinal disorders | Systematic Assessment |
|
| Anastomosis leakage | Gastrointestinal disorders | Systematic Assessment |
|
| Tachypnea with hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |