Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision
NCT ID: NCT03870685
Last Updated: 2021-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
43 participants
INTERVENTIONAL
2018-07-05
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
TAP Block
Transversus Plane block
Exparel
liposomal bupivacaine
Surgical Site Infiltration of Exparel
Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon.
Surgical Site Infiltration
Surgical Site Infiltration
Exparel
liposomal bupivacaine
Interventions
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TAP Block
Transversus Plane block
Surgical Site Infiltration
Surgical Site Infiltration
Exparel
liposomal bupivacaine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Danbury Hospital
OTHER
Responsible Party
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Linus Chuang
Network Chairman OB/GYN
Principal Investigators
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Linus Chuang, MD
Role: PRINCIPAL_INVESTIGATOR
Danbury Hospital, Nuvance Health
Locations
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Danbury Hospital
Danbury, Connecticut, United States
Countries
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References
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Atim A, Bilgin F, Kilickaya O, Purtuloglu T, Alanbay I, Orhan ME, Kurt E. The efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing hysterectomy. Anaesth Intensive Care. 2011 Jul;39(4):630-4. doi: 10.1177/0310057X1103900415.
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis. Br J Anaesth. 2012 Nov;109(5):679-87. doi: 10.1093/bja/aes279. Epub 2012 Aug 19.
Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15.
Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
Hotta K, Inoue S, Taira K, Sata N, Tamai K, Takeuchi M. Comparison of the analgesic effect between continuous wound infiltration and single-injection transversus abdominis plane block after gynecologic laparotomy. J Anesth. 2016 Feb;30(1):31-8. doi: 10.1007/s00540-015-2083-z. Epub 2015 Oct 14.
Gasanova I, Alexander J, Ogunnaike B, Hamid C, Rogers D, Minhajuddin A, Joshi GP. Transversus Abdominis Plane Block Versus Surgical Site Infiltration for Pain Management After Open Total Abdominal Hysterectomy. Anesth Analg. 2015 Nov;121(5):1383-8. doi: 10.1213/ANE.0000000000000909.
Other Identifiers
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18-701
Identifier Type: -
Identifier Source: org_study_id
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