Clinical trial NCT03702621: Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Official title: Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Surgery
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. LB group (Liposomal Bupivacaine)
2. SB group (Standard Bupivacaine)
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS Score at 1 Hour at Rest
timeFrame: Pain scores will be measured 1 hour after surgery
measure: VAS Score at 1 Hour With Movement
timeFrame: Pain scores will be measured 1 hour after surgery
measure: VAS Score at 24 Hours at Rest
timeFrame: Pain scores will be measured 24 hours after surgery
measure: VAS Score at 24 Hours With Movement
timeFrame: Pain scores will be measured 24 hours after surgery
measure: VAS Score at 48 Hours at Rest
timeFrame: Pain scores will be measured 48 hours after surgery
measure: VAS Score at 48 Hours With Movement
timeFrame: Pain scores will be measured 48 hours after surgery
measure: VAS Score at 72 Hours at Rest
timeFrame: Pain scores will be measured 72 hours after surgery
measure: VAS Score at 72 Hours With Movement
timeFrame: Pain scores will be measured 72 hours after surgery
Secondary outcomes:
measure: Total Opioid Consumption at 1 Hour
timeFrame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded
measure: Total Opioid Consumption at 24 Hour
timeFrame: Opioid consumption will be measured at 24 hour post op. The total amount will be recorded
measure: Total Opioid Consumption at 48 Hour
timeFrame: Opioid consumption will be measured at 48 hour post op. The total amount will be recorded
measure: Total Opioid Consumption at 72 Hour
timeFrame: Opioid consumption will be measured at 72 hour post op. The total amount will be recorded
Other outcomes:
measure: Nausea Scores (None) at 1 Hour
timeFrame: Nausea scores will be measured at 1 hour post-op.
measure: Nausea Scores (Mild) at 1 Hour
timeFrame: Nausea scores will be measured at 1 hour post-op.
measure: Nausea Scores (Moderate) at 1 Hour
timeFrame: Nausea scores will be measured at 1 hour post-op.
measure: Nausea Scores (Severe) at 1 Hour
timeFrame: Nausea scores will be measured at 1 hour post-op.
measure: Nausea Scores (None) at 24 Hours
timeFrame: Nausea scores will be measured at 24 hours post-op.
measure: Nausea Scores (Mild) at 24 Hours
timeFrame: Nausea scores will be measured at 24 hours post-op.
measure: Nausea Scores (Moderate) at 24 Hours
timeFrame: Nausea scores will be measured at 24 hours post-op.
measure: Nausea Scores (Severe) at 24 Hours
timeFrame: Nausea scores will be measured at 24 hours post-op.
measure: Nausea Scores (None) at 48 Hours
timeFrame: Nausea scores will be measured at 48 hours post-op.
measure: Nausea Scores (Mild) at 48 Hours
timeFrame: Nausea scores will be measured at 48 hours post-op.
measure: Nausea Scores (Moderate) at 48 Hours
timeFrame: Nausea scores will be measured at 48 hours post-op.
measure: Nausea Scores (Severe) at 48 Hours
timeFrame: Nausea scores will be measured at 48 hours post-op.
measure: Nausea Scores (None) at 72 Hours
timeFrame: Nausea scores will be measured at 72 hours post-op.
measure: Nausea Scores (Mild) at 72 Hours
timeFrame: Nausea scores will be measured at 72 hours post-op.
measure: Nausea Scores (Moderate) at 72 Hours
timeFrame: Nausea scores will be measured at 72 hours post-op.
measure: Nausea Scores (Severe) at 72 Hours
timeFrame: Nausea scores will be measured at 72 hours post-op.
measure: Sedation Scores (Awake/Alert) at 1 Hour
timeFrame: Sedation scores will be documented at 1 hour post-op.
measure: Sedation Scores (Quietly Awake) at 1 Hour
timeFrame: Sedation scores will be documented at 1 hour post-op.
measure: Sedation Scores (Asleep/Arousable) at 1 Hour
timeFrame: Sedation scores will be documented at 1 hour post-op.
measure: Sedation Scores (Deep Sleep) at 1 Hour
timeFrame: Sedation scores will be documented at 1 hour post-op.
measure: Sedation Scores (Awake/Alert) at 24 Hours
timeFrame: Sedation scores will be documented at 24 hours post-op.
measure: Sedation Scores (Awake/Alert) at 48 Hours
timeFrame: Sedation scores will be documented at 48 hours post-op.
measure: Sedation Scores (Awake/Alert) at 72 Hours
timeFrame: Sedation scores will be documented at 72 hours post-op.
measure: Surgery Duration
timeFrame: Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)
measure: Length of Stay
timeFrame: Time Frame for Admission to Discharge (usually within 3-7 days)
measure: Time to Flatus
timeFrame: End of Surgery until first reported Flatus (usually within 3 to 5 days)
measure: Time to Bowel Movement
timeFrame: End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)
measure: Time to Per Os
timeFrame: Time from end of surgery to time of Os (usually 4-16 hours)
measure: Ambulatory Postoperatively
timeFrame: End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeap YL, Wolfe J, Stewart J, McCutchan A, Chawla G, Robb B, Holcomb B, Vickery B. Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. Pain Manag. 2022 Jan;12(1):35-43. doi: 10.2217/pmt-2021-0033. Epub 2021 Sep 23.