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This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.
The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel, Liposomal Bupivacaine | Experimental | Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing |
|
| Control | Active Comparator | Subjects in this arm will receive 0.25% bupivacaine alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. | 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. | 48 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alisan Fathalizadeh, M.D | Staff | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel, Liposomal Bupivacaine | Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine |
| FG001 | Control | Subjects in this arm will receive 0.25% bupivacaine alone Bupivacaine: 60cc Bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel, Liposomal Bupivacaine | Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine |
| BG001 | Control |
| 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 | Post-Operative Pain | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. | Posted | Mean | Standard Deviation | units on a Visual Analog Scale (VAS) | 24 hours post-surgery |
|
1 year
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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 | Exparel, Liposomal Bupivacaine | Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Kroh | Cleveland Clinic Foundation | 12164457410 | krohm@ccf.org |
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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 | Mar 23, 2020 | Feb 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2020 | Feb 17, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | 60cc Bupivacaine |
|
Subjects in this arm will receive 0.25% bupivacaine alone Bupivacaine: 60cc Bupivacaine |
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-Operative Pain | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. | Posted | Mean | Standard Deviation | units on a Visual Analog Scale (VAS) | 48 hours post-surgery |
|
|
|
| 0 |
| 50 |
| 10 |
| 50 |
| 14 |
| 50 |
| EG001 | Control | Subjects in this arm will receive 0.25% bupivacaine alone Bupivacaine: 60cc Bupivacaine | 0 | 52 | 15 | 52 | 27 | 52 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Left Side Pain | General disorders | Systematic Assessment |
|
| Right Flank Pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Abdominal Abscess | Infections and infestations | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Post Operative Complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pain- Not otherwise Specified | General disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Wound Drainage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Pelvic Pain | General disorders | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vaginal Bleed | Reproductive system and breast disorders | Systematic Assessment |
|
| Leg Burn | General disorders | Systematic Assessment |
|
| Left Ankle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Foot Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abnormal labs | Investigations | Systematic Assessment |
|
| Black Stool | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Left Side Pain | General disorders | Systematic Assessment |
|
| Swollen Leg | General disorders | Systematic Assessment |
|
| Right Eye Complaint | Eye disorders | Systematic Assessment |
|
| Infection- Not otherwise Specified | Infections and infestations | Systematic Assessment |
|
| Hip Pain | General disorders | Systematic Assessment |
|
| Congestion | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000588 |
| Amines |