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Completed

NCT Number: NCT04300231

Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

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Key information

Conditions

Cystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Indiana Univeristy

Indianapolis, Indiana, 46202, United States

About this study

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder). By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (feeling sick to your stomach, feeling drowsy/sleepy, blockage/lack of movement in the intestines, inability to completely empty the bladder, unusually slow or shallow breathing).

The specific aim of this study is to compare the difference between the pain control methods in achieving the following:

  • Decreased opioid requirements
  • Improved postoperative VAS pain scores
  • Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression)
  • Decreased hospital length of stay (LOS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing cystectomy for bladder cancer
  • ASA class 1, 2, 3 or 4
  • Age 18 or older, male or female
  • Desires Regional anesthesia for postoperative pain control

Exclusion criteria

  • Any contraindication for thoracic epidural.
  • History of substance abuse in the past 6 months.
  • Patients on more than 30mg morphine equivalents of opioids daily.
  • Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine, Hydromorphone).
  • Postoperative intubation.
  • Any patient with history of neuropathic bowel or bladder dysfunction

Treatment and study plan

epidural bupivacaine 0.05%

Drug

Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.

Liposomal bupivacaine

Drug

20 ml

Bupivacaine 0.125%

Drug

40 mL

Bupivacaine 0.5%

Drug

60 mL

/hydromorphone 0.05mg/ml

Drug

Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.

injectable saline

Drug

40 mL

Primary outcomes

  1. VAS Score at 48 Hour

    Time frame: Pain scores will be measured 48 hours after surgery

    The VAS score 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 0-10 for documentation with 10 being the worst pain and 0 being no pain

  2. VAS Score at 72 Hour

    Time frame: Pain scores will be measured 72 hours after surgery

    The VAS score 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 0-10 for documentation with 10 being the worst pain and 0 being no pain

Secondary outcomes

  1. Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose

    Time frame: Opioid comsumption will be measured at 1 hour

    Opioid consumption will be collected by a study team member post operatively at hour 1 per protocol time requirements

  2. Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose

    Time frame: Opioid comsumption will be measured at 24 hours

    Opioid consumption will be collected by a study team member post operatively at hour 24 per protocol time requirements

  3. Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose

    Time frame: Opioid comsumption will be measured at 48 hours

    Opioid consumption will be collected by a study team member post operatively at hour 48 per protocol time requirements

  4. Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose

    Time frame: Opioid comsumption will be measured at 72 hours

    Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements

  5. Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose

    Time frame: Opioid comsumption will be measured at 96 hours

    Opioid consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements

  6. VAS Score at 1 Hour

    Time frame: Pain scores will be measured 1 hour after surgery

    The VAS score 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 0-10 for documentation with 10 being the worst pain and 0 being no pain

  7. VAS Score at 24

    Time frame: Pain scores will be measured 24 hours after surgery

    The VAS score 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 0-10 for documentation with 10 being the worst pain and 0 being no pain

  8. VAS Score at 96 Hour

    Time frame: Pain scores will be measured 96 hours after surgery

    The VAS score 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 0-10 for documentation with 10 being the worst pain and 0 being no pain

  9. Number of Participants With Nausea at 1 Hour

    Time frame: 1 hour

    Nausea scores will be collected by study team member post operatively at hour 1 per protocol. Result is reported as nausea or no nausea.

  10. Number of Participants With Nausea at 24 Hours

    Time frame: 24 hour

    Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Result is reported as nausea or no nausea.

  11. Number of Participants With Nausea at 48 Hours

    Time frame: 48 hour

    Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Result is reported as nausea or no nausea.

  12. Number of Participants With Nausea at 72 Hours

    Time frame: 72 hour

    Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Result is reported as nausea or no nausea.

  13. Number of Participants With Nausea at 96 Hours

    Time frame: 96 hour

    Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Result is reported as nausea or no nausea.

  14. Number of Participants With Sedation at 1 Hour

    Time frame: 1 hour

    Sedation scores will be collected by a study team member post operatively at hour 1. Results are interpreted as patient with or without any sedation.

  15. Number of Participants With Sedation at 24 Hours

    Time frame: 24 hour

    Sedation scores will be collected by a study team member post operatively at hour 24. Results are interpreted as patient with or without any sedation.

  16. Number of Participants With Sedation at 48 Hours

    Time frame: 48 hour

    Sedation scores will be collected by a study team member post operatively at hour 48. Results are interpreted as patient with or without any sedation.

  17. Number of Participants With Sedation at 72 Hours

    Time frame: 72 hour

    Sedation scores will be collected by a study team member post operatively at hour 72. Results are interpreted as patient with or without any sedation.

  18. Number of Participants With Sedation at 96 Hours

    Time frame: 96 hour

    Sedation scores will be collected by a study team member post operatively at hour 96. Results are interpreted as patient with or without any sedation.

  19. First Flatus-bowel Movement

    Time frame: Assess daily until patient passes gas postoperatively, up to 120 hours after surgery

    The first time the patients passes gas post operatively.

  20. Postoperative Creatinine

    Time frame: Creatinine level will be collected daily postoperatively for 4 days

    Lab level of Creatinine will be recorded for 4 days post operatively.

  21. Time to Discharge-Length of Stay

    Time frame: From hospital admission to discharge time

    Length of Stay will be collected from Cerner Electronic Medical Record. Pt. followed for length of stay, up till 4 weeks after surgery.

  22. Incidence of Hypotension

    Time frame: number of times hypotension occurred the first 96 hours after surgery.

    Defined as BP decrease of more than 20% from baseline. The reported number for each arm is the cumulative number of hypotension episodes experienced in each arm.

  23. Incidence of Respiratory Depression

    Time frame: assess daily as yes/no up to 96hr

    Define by use of Narcan

  24. Ambulation Activity Postoperatively

    Time frame: Patients followed for ambulation activities on postop Day 1 and Day 2

    Number of participants who got out of bed and is ambulatory on Postoperative Day 1 and postoperative Day 2

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2020
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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