NCT04003987

Brief Summary

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 5, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

May 23, 2019

Results QC Date

March 28, 2022

Last Update Submit

June 8, 2022

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.

    Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

    1 hour after surgery

  • Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.

    Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)

    24 hours after surgery

  • Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.

    Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)

    48 hours after surgery

  • Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.

    Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

    1 hour after surgery

  • Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.

    Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)

    24 hours after surgery

  • Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.

    Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)

    48 hours after surgery

Secondary Outcomes (8)

  • Patient Sedation Score at 1 Hour

    1 hour after surgery

  • Patient Sedation Score at 24 Hours

    24 hours after surgery

  • Patient Sedation Score at 48 Hours

    48 hours after surgery

  • Patient Nausea Score at 1 Hour

    1 hour after surgery

  • Patient Nausea Score at 24 Hour

    24 hour after surgery

  • +3 more secondary outcomes

Study Arms (2)

ESP Block

ACTIVE COMPARATOR

For the ESP block the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected (40 ml into each side; 20 ml injected at T8 and 20 ml injected at T12)

Drug: Liposomal bupivacaineDrug: bupivacaine, 0.125%

TAP Block

ACTIVE COMPARATOR

For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected (40 ml into each side; 20 ml injected for subcostal TAP and 20 ml injected for posterior TAP).

Drug: Liposomal bupivacaineDrug: bupivacaine, 0.125%

Interventions

Liposomal bupivacaineDRUG

20ml

Also known as: Exparel
ESP BlockTAP Block
bupivacaine, 0.125%DRUG

60ml

Also known as: bupivacaine
ESP BlockTAP Block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital
  • ASA class 1, 2, 3 or 4
  • Age 18 or older, female
  • Desires Regional anesthesia for postoperative pain control

You may not qualify if:

  • History of substance abuse in the past 6 months.
  • Patients on more than 30 mg morphine equivalents of opioids.
  • Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
  • Postoperative intubation.
  • Any BMI greater than 40.0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana Univeristy

Indianapolis, Indiana, 46202, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (10)

  • Shaffer EE, Pham A, Woldman RL, Spiegelman A, Strassels SA, Wan GJ, Zimmerman T. Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs. Adv Ther. 2017 Jan;33(12):2211-2228. doi: 10.1007/s12325-016-0438-y. Epub 2016 Nov 9.

    PMID: 27830448RESULT

  • Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.

    PMID: 27856266RESULT

  • Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.

    PMID: 29723644RESULT

  • Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

    PMID: 30292068RESULT

  • Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.

    PMID: 30288093RESULT

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016RESULT

  • Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.

    PMID: 27673545RESULT

  • Hadzic A, Minkowitz HS, Melson TI, Berkowitz R, Uskova A, Ringold F, Lookabaugh J, Ilfeld BM. Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty. Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.

    PMID: 27035853RESULT

  • Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.

    PMID: 27443874RESULT

  • Warner M, Yeap YL, Rigueiro G, Zhang P, Kasper K. Erector spinae plane block versus transversus abdominis plane block in laparoscopic hysterectomy. Pain Manag. 2022 Nov;12(8):907-916. doi: 10.2217/pmt-2022-0037. Epub 2022 Oct 10.

    PMID: 36214314DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Yar Yeap
Organization
Indiana University School of Medicine
yyeap@iupui.edu
(317) 274-0275

Study Officials

  • Yar Yeap, MD

    Indiana University Hospital

    PRINCIPAL INVESTIGATOR

  • Matthew Warner, MD

    Indiana University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Both the patients and the research staff doing assessments will be blinded to the randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. ESP Block Group 2. TAP Block Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Acute Pain Service Assistant Professor of Clinical Anesthesiololgy Department of Anesthesiology

Study Record Dates

First Submitted

May 23, 2019

First Posted

July 1, 2019

Study Start

May 1, 2019

Primary Completion

March 4, 2021

Study Completion

March 4, 2021

Last Updated

July 5, 2022

Results First Posted

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)