Nephrectomy Clinical Trial
Official title:
Randomized, Prospective, Study Comparing Four-quadrant Transverses Abdominis Plane (TAP) Block, Quadratus Lumborum (QL) Block and Surgeon Infiltration Using Exparel for Postoperative Analgesia After Laparoscopic Nephrectomy
Verified date | June 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
All three methods of postoperative analgesia have been shown to decrease postoperative pain control in nephrectomy patients, the three methods have never been compared to each other. This study aims to compare three different pain techniques proven to be beneficial in surgical nephrectomies, including the efficacy and the side effects of each technique.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 17, 2020 |
Est. primary completion date | November 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing laparoscopic nephrectomy including partial, simple and radical nephrectomy - ASA class 1, 2, 3 or 4 - Age 18 or older, male or female Exclusion Criteria: - Any contraindication for TAP block, QL block or surgeon infiltration - Donor Nephrectomy - History of substance abuse in the past 6 months - Patients on more than 30mg po morphine equivalents of opioids, staff anesthesiologist will confirm this portion prior to enrollment. - Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. - Known allergy to bupivacaine or Exparel - Patients <40kg or >110 kg TBW |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Average Nausea scores over 72 hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate or severe | Nausea scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged | |
Other | Average Sedation scores over 72 hours | Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake and alert, quietly awake, asleep and arousable, or deep sleep | Sedation scores will be documented at 1 hour post op, 24, 48, and 72 hours after the block. The scores will then be averaged | |
Other | Subjects overall satisfaction scores | Subjects will be followed up to 24 hours post operatively by a study team member to document patient overall satisfaction scores | Post operatively at hour 24 | |
Other | Subjects overall satisfaction scores | Subjects will be followed up to 48 hours post operatively by a study team member | Post operatively at hour 48 | |
Primary | Primary endpoint of this study will be VAS pain score at 24 hours | The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 24 hours after surgery | |
Primary | Primary endpoint of this study will be VAS pain score at 48 hours | Pain scores will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 48 hours after surgery | |
Secondary | Secondary endpoint includes total IV and PO (By Mouth) opioid consumption at 72 hours | Opioid consumption will be collected by a study team member post-operatively up to 3 days per protocol time requirements | Opioid consumption will be measured at 1 hour post op, 24, 48, and 72 hours post op. The total amount will be recorded |
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