A Phase 4 interventional study of Liposomal Bupivacaine and Bupivacaine and Epinephrine in Pain, Postoperative, sponsored by University of Texas at Austin. Status unknown at 1 site in United States. Open to participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by University of Texas at Austin · Phase 4, Interventional, and Treatment
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 75 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Texas at Austin is the lead sponsor of 326 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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The treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block.
Drug: Liposomal Bupivacaine · Drug: Bupivacaine and Epinephrine
The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block.
Drug: Bupivacaine and Epinephrine
At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.
Drug pages: Bupivacaine · Epinephrine
At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.
Duration of hospitalization status post jaw surgery
The amount of time spent in the hospital after the surgery
Time frame: Until discharge from hospital, an average of 3 days
Total morphine-equivalents
Amount of morphine-equivalents consumed by patient
Time frame: First 48 hours after surgery
Pain Scores
On a 1-10 visual analogue scale, measured per nursing with vital signs
Time frame: Until discharge from hospital, an average of 3 days
Oral intake
Oral intake measured in cc
Time frame: First 48 hours after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine
University of Texas at Austin →