Health TrialsbyHealthPanel

Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy

ConditionPain, Postoperative
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 66.5kg weight

elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights.

Disqualifiers

Combined operation or alternative approach

inpatient overnight admission

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combined Bupivacaine and Exparel

    Drug

    In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.

  • Normal Saline (NS)

    Drug

    In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Combined Bupivacaine and ExparelExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain as assessed by the visual analog scale (VAS)

Pain will be scored from 1-10 , higher number indicating more pain

Time frame
4-6 hours post operation, postoperative day 1, postoperative day 3

Secondary outcomes

1

Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed

Time frame
2-week and 6- week follow up
2

Change in level of pain control achieved as assessed by the frequency of NSAIDS needed

Time frame
2-week and 6- week follow up
3

Change in level of pain control achieved as assessed by the amount of opioids needed

Time frame
2-week and 6- week follow up
4

Change in level of pain control achieved as assessed by the frequency of opioids needed

Time frame
2-week and 6- week follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: