Liposomal bupivacaine
Drug20ml
Other names: Exparel
NCT Number: NCT04003987
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
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Notify Me18 year and older
Female
Interventional
Phase 3
Indiana Univeristy, Indianapolis, Indiana, United States
For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. [10]
For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected.
All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain.
Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20ml
Other names: Exparel
60ml
Other names: bupivacaine
Time frame: 1 hour after surgery
Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 24 hours after surgery
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 48 hours after surgery
Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Time frame: 1 hour after surgery
Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 24 hours after surgery
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)
Time frame: 48 hours after surgery
Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)
Time frame: 1 hour after surgery
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 24 hours after surgery
Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 48 hours after surgery
Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)
Time frame: 1 hour after surgery
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 24 hour after surgery
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 48 hour after surgery
Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)
Time frame: 24 hours after surgery
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Time frame: 48 hours after surgery
patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)
Indiana University
Other
Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy
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