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

NCT03870685 | Unknown Phase 4 FDA Drug

• 1 other identifier: 18-701
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption over 48 hours

  Total postoperative opioid consumption as measured by morphine milligram equivalents (MME)

  over 48 hour period after surgery

Secondary Outcomes (4)

• Pain scores at rest and upon exertion

  2 hours, 6 hours, 12 hours, 24 hours and 48 hours postoperatively

• Severity of nausea

  2, 6, 12, 24, & 48 hours postoperatively

• Episodes of vomiting

  48 hours postoperatively

• Total antiemetics consumption

  48 hour postoperatively

Study Arms (2)

TAP block with Exparel

ACTIVE COMPARATOR

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; Drug: Exparel

Surgical Site Infiltration of Exparel

ACTIVE COMPARATOR

Patients will receive surgical site infiltration of Exparel (liposomal bupivacaine) admixed with bupivacaine HCl and saline by surgeon.

Procedure: Surgical Site Infiltration; Drug: Exparel

Interventions

TAP Block PROCEDURE

Transversus Plane block

TAP block with Exparel

Surgical Site Infiltration PROCEDURE

Surgical Site Infiltration

Surgical Site Infiltration of Exparel

Exparel DRUG

liposomal bupivacaine

Surgical Site Infiltration of Exparel; TAP block with Exparel

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danbury Hospital: lead

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Related Publications (9)

• 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.

  PMID: 21823381 BACKGROUND

• 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.

  PMID: 19020158 BACKGROUND

• 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.

  PMID: 22907337 BACKGROUND

• 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.

  PMID: 27307177 BACKGROUND

• 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.

  PMID: 21928388 BACKGROUND

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 23049275 BACKGROUND

• 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.

  PMID: 26467038 BACKGROUND

• 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.

  PMID: 26252171 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Linus Chuang, MD

  Danbury Hospital, Nuvance Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Network Chairman OB/GYN

Model Details: Patients randomized to TAP block with liposomal bupivacaine OR surgical site infiltration of liposomal bupivacaine for postoperative analgesia after undergoing midline laparotomy

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: July 5, 2018
• Primary Completion: February 15, 2021
• Study Completion: December 31, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)