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Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Phase 4 trial testing Exparel in Post-operative Pain Management in 102 participants. Completed in 1 February 2021.
| Lead sponsor | Matthew Kroh |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 1 June 2017 |
| Primary completion | 26 January 2021 |
| Estimated completion | 1 February 2021 |
| Sites | 1 location across United States |
Matthew Kroh
18 and older, any sex, with Post-operative Pain Management. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
| Group | Value | 95% CI |
|---|---|---|
| Exparel, Liposomal Bupivacaine | 49.4 | ± 29 |
| Control | 56.6 | ± 26.4 |
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
| Group | Value | 95% CI |
|---|---|---|
| Exparel, Liposomal Bupivacaine | 42.2 | ± 30 |
| Control | 51.5 | ± 31.4 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Exparel, Liposomal Bupivac… | Control |
|---|---|---|---|
| Abdominal Pain | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Nausea | General disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Small Bowel Obstruction | Gastrointestinal disorders | — | — |
| Stroke | Vascular disorders | — | — |
| Bleeding | Blood and lymphatic system disorders | — | — |
| Dehydration | General disorders | — | — |
| Chest Pain | General disorders | — | — |
| Left Side Pain | General disorders | — | — |
| Right Flank Pain | General disorders | — | — |
| Chills | General disorders | — | — |
| Fever | General disorders | — | — |
| Abdominal Abscess | Infections and infestations | — | — |
| Wound Infection | Infections and infestations | — | — |
| Post Operative Complications | Injury, poisoning and procedural complications | — | — |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Exparel, Liposomal Bupivac… | Control |
|---|---|---|---|
| Abdominal Pain | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Chest Pain | General disorders | — | — |
| Nausea | General disorders | — | — |
| Pain- Not otherwise Specified | General disorders | — | — |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | — | — |
| Knee Pain | Musculoskeletal and connective tissue disorders | — | — |
| Foot Pain | Musculoskeletal and connective tissue disorders | — | — |
| Dehydration | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | General disorders | — | — |
| Bleeding | Blood and lymphatic system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Wound Drainage | Injury, poisoning and procedural complications | — | — |
| Pelvic Pain | General disorders | — | — |
| Vaginal Bleed | Reproductive system and breast disorders | — | — |
| Leg Burn | General disorders | — | — |
| Left Ankle Pain | Musculoskeletal and connective tissue disorders | — | — |
| Abnormal labs | Investigations | — | — |
| Black Stool | Gastrointestinal disorders | — | — |
| Left Side Pain | General disorders | — | — |
| Swollen Leg | General disorders | — | — |
| Right Eye Complaint | Eye disorders | — | — |
| Infection- Not otherwise Specified | Infections and infestations | — | — |
| Hip Pain | General disorders | — | — |
| Congestion | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Abdominal Pain, Vomiting, Nausea, Ileus, Pneumonia, Small Bowel Obstruction, Stroke, Bleeding.
Data from ClinicalTrials.gov NCT03187379 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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