A Study to Compare Total Amount of Opioid Use in the First 72 Hours Following Vaginal Hysterectomy Surgery

Overview

About this study

The purpose of this study is to compare total amount of opioid use in the first 72 hours following surgery, calculated as morphine equivalents using standard conversion.

Secondary outcome measures include pain scores, non-opioid medication use, nausea, vomiting, length of hospital stay, and patient satisfaction of pain management.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Women with ages between 18-85 years old  
  • Undergoing outpatient vaginal hysterectomy with or without concurrent prolapse repair surgeries at the Mayo Clinic Hospital in Arizona

Exclusion Criteria:

  • Hepatic disease 
  • History of chronic pain or current opioid use 
  • Allergy to local amide anesthetic 
  • Dementia or mental retardation 
  • ASA status greater than II

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeffrey Cornella, M.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Nalani Thomas B.S.

(480) 342-0349

Thomas.Nalani@mayo.edu

More information

Publications

  • Local infiltration analgesia (LIA) with liposomal bupivacaine (LB) in patients undergoing total knee arthroplasty (TKA) has yielded mixed results. The PILLAR study, which was designed to minimize limitations associated with previous studies, compared the effects of LIA with or without LB on pain scores, opioid consumption, including proportion of opioid-free patients, time to first opioid rescue, and safety after primary unilateral TKA. Read More on PubMed
  • Optimal pain control after major surgery contributes to a patient's recovery and satisfaction. The use of liposomal bupivacaine in subcostal transversus abdominis plane (TAP) blocks for postoperative pain control after robot assisted abdominal surgery has yet to be studied. Read More on PubMed
  • To investigate the effects of enhanced recovery (a multimodal perioperative care enhancement protocol) in patients undergoing gynecologic surgery. Read More on PubMed
  • Liposome bupivacaine is a novel formulation of the local anesthetic bupivacaine, designed to provide prolonged postsurgical analgesia. This analysis examined pooled efficacy data as reflected in cumulative pain scores from 10 randomized, double-blind liposome bupivacaine clinical studies in which the study drug was administered via local wound infiltration. Read More on PubMed
  • Preemptive analgesia in vaginal surgery has had conflicting efficacy reported in the existing literature. This study was designed to clarify the usefulness of preemptive local analgesia (PLA) in patients undergoing vaginal hysterectomy. A prospective, randomized, double-blinded trial of PLA in 90 women undergoing vaginal hysterectomy was conducted. PLA consisted of 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine injected in a paracervical-type fashion. Total narcotic use and pain (using a visual analog scale (VAS)) was recorded at 30 min, 3, 12, and 24 h postoperatively. The mean total dose of narcotic was significantly less in the PLA group versus the placebo group (P = 0.009) at every time point postoperatively. Additionally, the mean pain VAS 30 min and 3 h postoperatively was 43% (P = 0.003) and 33% (P = 0.02) lower, respectively, in the PLA group. PLA with bupivacaine prior to vaginal hysterectomy is associated with significantly lower pain scores and a reduction in narcotic use postoperatively. Read More on PubMed
  • Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490295

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