Laparoscopic Assisted Plane Block (LAPB) Trial

NCT ID: NCT03730402

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-04
• Study Completion Date: 2021-04-14

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.

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.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

bupivacaine block

laparoscopic assisted plane block of standardized dose of bupivacaine plain

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

utilizing local anesthetic to perform a regional block under laparoscopic guidance

liposomal bupivacaine block (Exparel 266 milligram Per 20 ML)

laparoscopic assisted plane block of standardized dose of bupivacaine plain

Group Type: ACTIVE_COMPARATOR

Exparel 266 milligram Per 20 ML Injection

Intervention Type: DRUG

utilizing local anesthetic to perform a regional block under laparoscopic guidance

saline block

laparoscopic assisted plane block with placebo saline injection

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

placebo injection of saline

Interventions

Bupivacaine

utilizing local anesthetic to perform a regional block under laparoscopic guidance

Intervention Type: DRUG

Exparel 266 milligram Per 20 ML Injection

utilizing local anesthetic to perform a regional block under laparoscopic guidance

Intervention Type: DRUG

Saline

placebo injection of saline

Intervention Type: DRUG

Other Intervention Names

Marcaine; Exparel, liposomal bupivacaine; Injectable Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Santa Barbara Cottage Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Zerey, MD

Role: PRINCIPAL_INVESTIGATOR

Cottage Hospital, Sansum Clinic

Locations

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Countries

United States

Other Identifiers

18-66mr

Identifier Type: -

Identifier Source: org_study_id