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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03870685
• Other study ID #: 18-701
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 5, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Danbury Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 31, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

Procedure:
• TAP Block
Transversus Plane block
• Surgical Site Infiltration
Surgical Site Infiltration

Drug:
• Exparel
liposomal bupivacaine

Locations

Country	Name	City	State
United States	Danbury Hospital	Danbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Danbury Hospital

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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):1184-96. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain scores at rest and upon exertion	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
Secondary	Severity of nausea	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
Secondary	Episodes of vomiting	Total number of vomiting episodes will be collected from medical record.	48 hours postoperatively
Secondary	Total antiemetics consumption	Total antiemetics consumption (type of antiemetic, mode of administration, dose, time of administration) will be collected from medical record.	48 hour postoperatively