TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

NCT02519023 | Completed Phase 4 Results DMC

• 1 other identifier: 7152222222
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Total Opioid Use for Pain Control

  total opioid used from time 0 after surgery through 72 hours after surgery was complete.

  72 hours

Secondary Outcomes (13)

• Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)

  0-72 hours post-procedure

• Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

  0-24 post-procedure

• Quality of Recovery 15 (QoR15) Score

  72 hours post-procedure

• Overall Benefit of Analgesia Score (OBAS)

  72 hours post-procedure

• Number of Participants With Nausea and Vomiting

  72 hours post-procedure

Study Arms (2)

TAP-Block with liposomal bupivacaine

EXPERIMENTAL

TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.

Drug: Liposomal Bupivacaine; Device: Ultrasound; Drug: Epinephrine; Drug: acetaminophen; Drug: ibuprofen; Drug: Oxycodone

Surgical infiltration with bupivacaine

ACTIVE COMPARATOR

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

Drug: Bupivacaine; Device: Ultrasound; Drug: acetaminophen; Drug: ibuprofen; Drug: Oxycodone

Interventions

Liposomal Bupivacaine DRUG

In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.

Also known as: Exparel

TAP-Block with liposomal bupivacaine

Bupivacaine DRUG

Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.

Surgical infiltration with bupivacaine

Ultrasound DEVICE

An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane

Surgical infiltration with bupivacaine; TAP-Block with liposomal bupivacaine

Epinephrine DRUG

TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.

TAP-Block with liposomal bupivacaine

acetaminophen DRUG

all individuals will receive scheduled acetaminophen (1 gram every 6 hours),

Surgical infiltration with bupivacaine; TAP-Block with liposomal bupivacaine

ibuprofen DRUG

all individuals will receive scheduled ibuprofen (800 mg every 8 hours)

Surgical infiltration with bupivacaine; TAP-Block with liposomal bupivacaine

Oxycodone DRUG

all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.

Surgical infiltration with bupivacaine; TAP-Block with liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III
• Females \>/=18-years of age
• Scheduled for laparoscopic/robot-assisted hysterectomy.

You may not qualify if:

• Contraindication to surgical infiltration or regional blockade
• History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder
• Inability to understand the informed consent and demands of the study
• Surgery scheduled to start after 1700

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (5)

• Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.

  PMID: 25170277 BACKGROUND

• Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.

  PMID: 22381092 BACKGROUND

• Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

  PMID: 19561014 BACKGROUND

• Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.

  PMID: 20175754 BACKGROUND

• Singh M, Chin KJ, Chan V. Ultrasound-guided transversus abdominis plane (TAP) block: a useful adjunct in the management of postoperative respiratory failure. J Clin Anesth. 2011 Jun;23(4):303-6. doi: 10.1016/j.jclinane.2010.05.012.

  PMID: 21663815 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine; Ultrasonography; Epinephrine; Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Jacob Hutchins
• Organization: University of Minnesota

hutc0079@umn.edu

6122505535

Study Officials

• Melissa Geller, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 10, 2015
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 8, 2019
• Results First Posted: December 5, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)