Laparoscopic Assisted Plane Block (LAPB) Trial

• ClinicalTrials.gov Identifier: NCT03730402
• Recruitment Status: Terminated
• First Posted: November 5, 2018
• Last Update Posted: July 1, 2021
• Sponsor: Santa Barbara Cottage Hospital
• Information provided by (Responsible Party): Santa Barbara Cottage Hospital

Study Description

Brief Summary:

This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.

Condition or disease	Intervention/treatment	Phase
Opioid Use	Drug: Bupivacaine; Drug: Exparel 266 milligram Per 20 ML Injection; Drug: Saline	Phase 4

Detailed Description:

Patients will either be pre-screened prior to their pre-operative appointment for eligibility, or screening will occur on the day of surgery. Informed Consent will be obtained from amenable, eligible patients prior to their operation by a member of the research team. A study number will be assigned, and the patient will be randomized to a treatment group. The patients will not be aware to which treatment group they have been randomized.

After consent is obtained and randomization has been completed, the operating room registered nurse will calculate maximum dose of allowable bupivacaine per patient based on body weight. Anesthesia will provide the intravenous lidocaine bolus on induction to all patients without a contraindication to the medication. The port placement will occur using a needle to raise skin/preperitoneal wheal*. Up to 20cc of 1% lidocaine/epinephrine will be divided among all ports and stab incisions. At end of case, no further skin or port-specific preperitoneal anesthetic will be injected unless a skin incision was extended.

For patients randomized to port site injection (Control): 60 cc of sterile, preservative-free, injectable saline will be given as a placebo per the protocol in item 6.

For patients randomized to bupivacaine plain LAPB (Treatment Arm 1): The maximum weight-based dose of plain bupivacaine will be diluted with sterile, injectable, preservative-free saline to a total of 60cc with a maximum of 250mg bupivacaine (regardless of weight) and loaded into a 30cc syringe with a 22g spinal needle (one 30cc syringe used for each side).

For patients randomized to liposomal bupivacaine LAPB (Treatment Arm 2): The maximum dose for adult patients is 266mg (20mL) of liposomal bupivacaine. This will be diluted with 40cc of preservative-free normal saline for injection, per manufacturer recommendations. The solution will then be loaded into a 30cc syringe with a 22g spinal needle and injected in the same fashion as the bupivacaine plain LAPB.

Data collection will include total doses of IV and skin and block anesthetic used, patient weight, number and size of ports, if fascial closure of port site was conducted, and post-operative narcotic medication used up to 48 hours with timing and doses marked, and use of any pain adjuncts (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen, gabapentin, tricyclic antidepressants [TCA], pregabalin, clonidine, etc.) although doses of these medications are not to be recorded.

Provision of home narcotic prescription will be based on a standardized protocol developed by Dartmouth. Based on the past 24 hours of pain medication usage, patients will receive either 15 or 30 tablets of hydrocodone/acetaminophen 5/325mg (or liquid equivalent for bariatric patients). Use of narcotic medications at home will be evaluated at 1 week post-procedure by a member of the research team through a phone survey.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomized control trial
• Masking: Single (Participant)
• Masking Description: single-blind study
• Primary Purpose: Other
• Official Title: Laparoscopic Assisted Plane Block (LAPB) Trial: Bupivacaine Versus Liposomal Bupivacaine Versus Standard Local Anesthesia for Post-operative Analgesia
• Actual Study Start Date: February 4, 2019
• Actual Primary Completion Date: April 14, 2021
• Actual Study Completion Date: April 14, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: bupivacaine block; laparoscopic assisted plane block of standardized dose of bupivacaine plain	Drug: Bupivacaine; utilizing local anesthetic to perform a regional block under laparoscopic guidance; Other Name: Marcaine
Active Comparator: liposomal bupivacaine block (Exparel 266 milligram Per 20 ML); laparoscopic assisted plane block of standardized dose of bupivacaine plain	Drug: Exparel 266 milligram Per 20 ML Injection; utilizing local anesthetic to perform a regional block under laparoscopic guidance; Other Name: Exparel, liposomal bupivacaine
Placebo Comparator: saline block; laparoscopic assisted plane block with placebo saline injection	Drug: Saline; placebo injection of saline; Other Name: Injectable Saline

Outcome Measures

Primary Outcome Measures :

1. Narcotic Usage [ Time Frame: 24 hours ]
   post-operative narcotic usage expressed in morphine equivalents

Secondary Outcome Measures :

1. Narcotic Usage [ Time Frame: 7 days ]
   post-operative narcotic usage expressed in morphine equivalents
2. Pain Scores [ Time Frame: 24 hours ]
   Visual Analog Score for pain (1-10)
3. Post-Operative Nausea [ Time Frame: 24 hours ]
   Post-operative nausea will be quantified through chart review by recording the amount of anti-emetic medication administered in the 24 hour period the patient is admitted post-operatively. This will allow objective quantification of nausea in the immediate post-operative period for analysis.
4. Post-operative emesis [ Time Frame: 24 hours ]
   Emesis is recorded as part of the standard intake/output medical charting, and the number of episodes of emesis will be quantified from chart review. This will be analyzed between groups to determine if the intervention has an impact on the number of episodes of post-operative emesis.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patients aged 18-80 years old
• Patients undergoing non-emergent laparoscopic surgery with planned or continued admission for at least 1 night
• Patients who receive fully laparoscopic procedures including ports up to 15mm, and any blunt dilation of port fascia or sharp extension of skin incisions for specimen extraction.

Exclusion Criteria:

• Patients under 18 or over 80 years old
• Patients who are pregnant
• Patients who are unable to consent themselves
• Patients who undergo an appendectomy for acute appendicitis
• Patients who undergo emergent surgery
• Patients who are converted to open procedure
• Patients who receive concurrent neuraxial anesthesia (spinal, epidural, or indwelling pain pumps)
• Patients who receive concurrent local anesthetic drips planned during or administered immediately after surgery
• Patients who have a contraindication to local anesthetics (e.g. verified allergy, severe hepatic dysfunction)
• Patients who use chronic narcotics

Contacts and Locations

Locations

United States, California

Santa Barbara Cottage Hospital

Santa Barbara, California, United States, 93105

Sponsors and Collaborators

Santa Barbara Cottage Hospital

Investigators

• Principal Investigator: Marc Zerey, MD; Cottage Hospital, Sansum Clinic

More Information

• Responsible Party: Santa Barbara Cottage Hospital
• ClinicalTrials.gov Identifier: NCT03730402
• Other Study ID Numbers: 18-66mr
• First Posted: November 5, 2018
• Last Update Posted: July 1, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Santa Barbara Cottage Hospital:

post-operative analgesia

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents