Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision

July 8, 2021 updated by: Linus Chuang, Danbury Hospital

Surgical Site Infiltration of Liposomal Bupivacaine Versus Transversus Plane Block With Liposomal Bupivacaine in Patients With Suspected or Known Gynecologic Cancer Undergoing Laparotomy Via Midline Incision

This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies undergoing midline laparotomy who received TAP block with liposomal bupivacaine versus surgical site infiltration of liposomal bupivacaine.

Primary outcome: Total postoperative opioid consumption as measured by morphine equivalents over 48 hour period.

Secondary outcomes include: Pain scores (based on visual analog scale 1-10) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively at rest and upon exertion (Valsalva maneuver), Severity of nausea, Episodes of vomiting, Total antiemetics consumption over 48 hour period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent studies suggest surgical site infiltration of local anesthetic into the preperitoneal, subfascial and/or subcutaneous planes as an alternative approach. The literature suggests this offers superior pain relief and significantly reduced morphine consumption. This procedure has been shown to provide excellent analgesia in open inguinal hernia repair and colorectal procedures up to 72 hours after a single injection. However, there is limited published data comparing TAP block with liposomal bupivacaine and surgical site infiltration of liposomal bupivacaine in open hysterectomy patients.

The investigators propose to prospectively study the efficacy of surgical site infiltration of liposomal bupivacaine versus TAP block with liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy. The investigators hypothesize that surgical site infiltration of liposomal bupivacaine is more effective than TAP block with liposomal bupivacaine in this patient population. The investigators primary outcome will be postoperative total 48 hour opioid consumption.

Secondary outcomes will include visual analog scale (VAS) pain scores at rest and upon exertion (Valsalva maneuver) at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively, severity of nausea, episodes of vomiting and total antiemetics consumption postoperatively. Pain scores and severity of nausea scores will be collected in person or over the phone.

The investigators expect the results of this study to demonstrate that surgical site infiltration of liposomal bupivacaine in patients with suspected or known gynecologic malignancies undergoing midline laparotomy may help shorten the recovery period and reduce the need for postoperative opioid medications. Furthermore, generally patients undergoing procedures such as tumor debulking and lymph node dissection would have an extended hospitalization. If surgical site infiltration of liposomal bupivacaine administration is found to decrease the length of hospitalization (versus TAP Block with liposomal bupivacaine), it will significantly decrease the health care costs.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any woman age 18 or over with known or suspected gynecologic malignancy who is scheduled for laparotomy via vertical midline incision at Danbury Hospital or Norwalk Hospital
  • American Society of Anesthesiologists physical status I to IV (a normal healthy patient to a patient with severe systemic disease that may be constant threat to life)
  • English or Spanish speaking

Exclusion Criteria:

  • Pregnancy
  • Unable to obtain consent
  • Severe allergies and/or anaphylaxis to bupivacaine or other anesthetics of the same class, to hydromorphone or morphine equivalents
  • Patients taking fospropofol, hyaluronidase, propofol, propranolol, St John's Wort and verapamil at the time of screening
  • Significant psychiatric disturbance as recorded in the medical record
  • Current or history of alcohol or drug addiction
  • Have current acute or chronic pain disorders as indicated in medical record
  • Current or history of opioid dependence
  • Contraindications to acetaminophen (significant hepatic dysfunction or disease), ketorolac and ibuprofen (significant renal dysfunction or reactive airway disease)
  • ≥2 previous midline laparotomies
  • BMI >45

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TAP block with Exparel
Patients will receive immediate postoperative bilateral 2-quadrant TAP block with Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by the anesthesia team.
Procedure: TAP Block
Transversus Plane block
Drug: Exparel
liposomal bupivacaine
ACTIVE_COMPARATOR: Surgical Site Infiltration of Exparel
Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon.
Drug: Exparel
liposomal bupivacaine
Procedure: Surgical Site Infiltration
Surgical Site Infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative opioid consumption over 48 hours
Time Frame: over 48 hour period after surgery
Total postoperative opioid consumption as measured by morphine milligram equivalents (MME)
over 48 hour period after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores at rest and upon exertion
Time Frame: 2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively
Pain scores based on Wong-baker FACES Pain Rating Scale (Visual analog scale (VAS)) at rest and upon exertion (Valsalva maneuver) will be collected in person or over the phone. 0 - no hurt, 2 - hurts little bit, 4 - hurts little more, 6 - hurts even more, 8 - hurts whole lot, 10 - hurts worst.
2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively
Severity of nausea
Time Frame: 2, 6, 12, 24, & 48 hours postoperatively
Severity of nausea will be collected in person or over the phone. Severity of Nausea Scale:- 0 = none, 1 = mild, 2 = moderate, 3 = severe
2, 6, 12, 24, & 48 hours postoperatively
Episodes of vomiting
Time Frame: 48 hours postoperatively
Total number of vomiting episodes will be collected from medical record.
48 hours postoperatively
Total antiemetics consumption
Time Frame: 48 hour postoperatively
Total antiemetics consumption (type of antiemetic, mode of administration, dose, time of administration) will be collected from medical record.
48 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danbury Hospital

Investigators

  • Principal Investigator: Linus Chuang, MD, Danbury Hospital, Nuvance Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2018

Primary Completion (ACTUAL)

February 15, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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