Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | July 5, 2018 |
| End Date: | July 5, 2021 |
| Contact: | Joann Petrini, PhD |
| Email: | Joann.petrini@wchn.org |
| Phone: | 203-739-6882 |
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.
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.
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.
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.
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
We found this trial at
1
site
Danbury, Connecticut 06810
Principal Investigator: Vaagn Andikyan, MD
Phone: 203-739-6882
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