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Completed

NCT Number: NCT03702621

Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

About this study

Quadratus lumborum (QL) blocks will be done intraoperatively after induction. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.

All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively. Patients above 70yo will receive 300mg gabapentin. Patient will be randomized to one of the two arms.

For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. For the liposomal bupivacaine (LB) group, 0.125% bupivacaine 20ml plus Exparel®10ml will then be injected into the fascial plane on each side. For the standard bupivacaine (SB) group. 30ml 0.25% bupivacaine will be injected on each side. Saline will be used for hydro-dissection until the QL block target is confirmed on ultrasound.

As part of the enhanced recovery after surgery (ERAS) protocol, all patients will receive ketamine and lidocaine drip during surgery, which is the investigator's current standard of practice.

All patients will be scheduled on PO acetaminophen and PO gabapentin daily postoperatively per ERAS protocol. PO oxycodone as needed (PRN) will be started once patients tolerate diet. PRN IV dilaudid may be given for severe breakthrough pain.

Opioid usage at 1, 24, 48 and 72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) 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, 48 and 72 hours after the QL block and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing colorectal surgery at Indiana University Hospital
  • American Society of Anesthesiologists (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 QL block.
  • 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).
  • Postoperative intubation.
  • Any BMI greater than 40.0.

Treatment and study plan

Liposomal bupivacaine

Drug

20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group

Bupivacaine Hydrochloride

Drug

40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.

60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group

Primary outcomes

  1. VAS Score at 1 Hour at Rest

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

    The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  2. VAS Score at 1 Hour With Movement

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

    The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  3. VAS Score at 24 Hours at Rest

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

    The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  4. VAS Score at 24 Hours With Movement

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

    The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  5. VAS Score at 48 Hours at Rest

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

    The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  6. VAS Score at 48 Hours With Movement

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

    The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  7. VAS Score at 72 Hours at Rest

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

    The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

  8. VAS Score at 72 Hours With Movement

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

    The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain

Secondary outcomes

  1. Total Opioid Consumption at 1 Hour

    Time frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded

    Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

  2. Total Opioid Consumption at 24 Hour

    Time frame: Opioid consumption will be measured at 24 hour post op. The total amount will be recorded

    Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

  3. Total Opioid Consumption at 48 Hour

    Time frame: Opioid consumption will be measured at 48 hour post op. The total amount will be recorded

    Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

  4. Total Opioid Consumption at 72 Hour

    Time frame: Opioid consumption will be measured at 72 hour post op. The total amount will be recorded

    Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements

Other outcomes

  1. Nausea Scores (None) at 1 Hour

    Time frame: Nausea scores will be measured at 1 hour post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  2. Nausea Scores (Mild) at 1 Hour

    Time frame: Nausea scores will be measured at 1 hour post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  3. Nausea Scores (Moderate) at 1 Hour

    Time frame: Nausea scores will be measured at 1 hour post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  4. Nausea Scores (Severe) at 1 Hour

    Time frame: Nausea scores will be measured at 1 hour post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  5. Nausea Scores (None) at 24 Hours

    Time frame: Nausea scores will be measured at 24 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  6. Nausea Scores (Mild) at 24 Hours

    Time frame: Nausea scores will be measured at 24 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  7. Nausea Scores (Moderate) at 24 Hours

    Time frame: Nausea scores will be measured at 24 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  8. Nausea Scores (Severe) at 24 Hours

    Time frame: Nausea scores will be measured at 24 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  9. Nausea Scores (None) at 48 Hours

    Time frame: Nausea scores will be measured at 48 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  10. Nausea Scores (Mild) at 48 Hours

    Time frame: Nausea scores will be measured at 48 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  11. Nausea Scores (Moderate) at 48 Hours

    Time frame: Nausea scores will be measured at 48 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  12. Nausea Scores (Severe) at 48 Hours

    Time frame: Nausea scores will be measured at 48 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  13. Nausea Scores (None) at 72 Hours

    Time frame: Nausea scores will be measured at 72 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  14. Nausea Scores (Mild) at 72 Hours

    Time frame: Nausea scores will be measured at 72 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  15. Nausea Scores (Moderate) at 72 Hours

    Time frame: Nausea scores will be measured at 72 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  16. Nausea Scores (Severe) at 72 Hours

    Time frame: Nausea scores will be measured at 72 hours post-op.

    Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe

  17. Sedation Scores (Awake/Alert) at 1 Hour

    Time frame: Sedation scores will be documented at 1 hour post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  18. Sedation Scores (Quietly Awake) at 1 Hour

    Time frame: Sedation scores will be documented at 1 hour post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  19. Sedation Scores (Asleep/Arousable) at 1 Hour

    Time frame: Sedation scores will be documented at 1 hour post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  20. Sedation Scores (Deep Sleep) at 1 Hour

    Time frame: Sedation scores will be documented at 1 hour post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  21. Sedation Scores (Awake/Alert) at 24 Hours

    Time frame: Sedation scores will be documented at 24 hours post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  22. Sedation Scores (Awake/Alert) at 48 Hours

    Time frame: Sedation scores will be documented at 48 hours post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  23. Sedation Scores (Awake/Alert) at 72 Hours

    Time frame: Sedation scores will be documented at 72 hours post-op.

    Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.

  24. Surgery Duration

    Time frame: Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)

    Duration of surgery will be collected per MR of surgeon documentation.

  25. Length of Stay

    Time frame: Time Frame for Admission to Discharge (usually within 3-7 days)

    Admission date until Admission Discharge

  26. Time to Flatus

    Time frame: End of Surgery until first reported Flatus (usually within 3 to 5 days)

    Hours for End of Surgery to first reported hour of Flatus

  27. Time to Bowel Movement

    Time frame: End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)

    Hours for End of Surgery to first reported hour of bowel movement

  28. Time to Per Os

    Time frame: Time from end of surgery to time of Os (usually 4-16 hours)

    Reported time after surgery to time of Os per MR or patient

  29. Ambulatory Postoperatively

    Time frame: End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)

    Number of patients who ambulated within 24 hours of end of surgery

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2018
Registry last updated
May 17, 2023

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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