Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702621
• Other study ID #: 1806187876
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• liposomal Bupivacaine
20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group
• Bupivacaine Hydrochloride
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

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea Scores (None) at 1 Hour	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	Nausea scores will be measured at 1 hour post-op.
Other	Nausea Scores (Mild) at 1 Hour	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	Nausea scores will be measured at 1 hour post-op.
Other	Nausea Scores (Moderate) at 1 Hour	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	Nausea scores will be measured at 1 hour post-op.
Other	Nausea Scores (Severe) at 1 Hour	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	Nausea scores will be measured at 1 hour post-op.
Other	Nausea Scores (None) at 24 Hours	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	Nausea scores will be measured at 24 hours post-op.
Other	Nausea Scores (Mild) at 24 Hours	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	Nausea scores will be measured at 24 hours post-op.
Other	Nausea Scores (Moderate) at 24 Hours	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	Nausea scores will be measured at 24 hours post-op.
Other	Nausea Scores (Severe) at 24 Hours	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	Nausea scores will be measured at 24 hours post-op.
Other	Nausea Scores (None) at 48 Hours	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	Nausea scores will be measured at 48 hours post-op.
Other	Nausea Scores (Mild) at 48 Hours	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	Nausea scores will be measured at 48 hours post-op.
Other	Nausea Scores (Moderate) at 48 Hours	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	Nausea scores will be measured at 48 hours post-op.
Other	Nausea Scores (Severe) at 48 Hours	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	Nausea scores will be measured at 48 hours post-op.
Other	Nausea Scores (None) at 72 Hours	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	Nausea scores will be measured at 72 hours post-op.
Other	Nausea Scores (Mild) at 72 Hours	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	Nausea scores will be measured at 72 hours post-op.
Other	Nausea Scores (Moderate) at 72 Hours	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	Nausea scores will be measured at 72 hours post-op.
Other	Nausea Scores (Severe) at 72 Hours	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	Nausea scores will be measured at 72 hours post-op.
Other	Sedation Scores (Awake/Alert) at 1 Hour	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.	Sedation scores will be documented at 1 hour post-op.
Other	Sedation Scores (Quietly Awake) at 1 Hour	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.	Sedation scores will be documented at 1 hour post-op.
Other	Sedation Scores (Asleep/Arousable) at 1 Hour	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.	Sedation scores will be documented at 1 hour post-op.
Other	Sedation Scores (Deep Sleep) at 1 Hour	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.	Sedation scores will be documented at 1 hour post-op.
Other	Sedation Scores (Awake/Alert) at 24 Hours	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.	Sedation scores will be documented at 24 hours post-op.
Other	Sedation Scores (Awake/Alert) at 48 Hours	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.	Sedation scores will be documented at 48 hours post-op.
Other	Sedation Scores (Awake/Alert) at 72 Hours	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.	Sedation scores will be documented at 72 hours post-op.
Other	Surgery Duration	Duration of surgery will be collected per MR of surgeon documentation.	Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)
Other	Length of Stay	Admission date until Admission Discharge	Time Frame for Admission to Discharge (usually within 3-7 days)
Other	Time to Flatus	Hours for End of Surgery to first reported hour of Flatus	End of Surgery until first reported Flatus (usually within 3 to 5 days)
Other	Time to Bowel Movement	Hours for End of Surgery to first reported hour of bowel movement	End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)
Other	Time to Per Os	Reported time after surgery to time of Os per MR or patient	Time from end of surgery to time of Os (usually 4-16 hours)
Other	Ambulatory Postoperatively	Number of patients who ambulated within 24 hours of end of surgery	End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)
Primary	VAS Score at 1 Hour at Rest	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	Pain scores will be measured 1 hour after surgery
Primary	VAS Score at 1 Hour With Movement	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	Pain scores will be measured 1 hour after surgery
Primary	VAS Score at 24 Hours at Rest	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	Pain scores will be measured 24 hours after surgery
Primary	VAS Score at 24 Hours With Movement	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	Pain scores will be measured 24 hours after surgery
Primary	VAS Score at 48 Hours at Rest	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	Pain scores will be measured 48 hours after surgery
Primary	VAS Score at 48 Hours With Movement	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	Pain scores will be measured 48 hours after surgery
Primary	VAS Score at 72 Hours at Rest	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	Pain scores will be measured 72 hours after surgery
Primary	VAS Score at 72 Hours With Movement	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	Pain scores will be measured 72 hours after surgery
Secondary	Total Opioid Consumption at 1 Hour	Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements	Opioid consumption will be measured at 1 hour post op. The total amount will be recorded
Secondary	Total Opioid Consumption at 24 Hour	Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements	Opioid consumption will be measured at 24 hour post op. The total amount will be recorded
Secondary	Total Opioid Consumption at 48 Hour	Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements	Opioid consumption will be measured at 48 hour post op. The total amount will be recorded
Secondary	Total Opioid Consumption at 72 Hour	Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements	Opioid consumption will be measured at 72 hour post op. The total amount will be recorded