NCT02506855

Brief Summary

This study attempts to learn about the effectiveness of a modification to the Transversus Abdominis Plane (TAP) block that works by anaesthetizing the sensory afferents of the abdominal wall postoperatively using ultrasound guidance. The investigators want to see if regional blocks placed by the surgeon intraoperatively to assure regional anesthetic spread in the appropriate plane could reduce error and improve postoperative recovery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

June 11, 2015

Last Update Submit

May 12, 2016

Conditions

Postoperative PainPostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Milligrams of Diludid Consumption During First 48 hours Following Surgery

    The amount of diludid received per participant will be recorded from participant medication record at the specified time frame.

    48 hours postoperatively

Secondary Outcomes (3)

  • Level of Nerve (Dermatome) Block

    4hrs postoperative and on postoperative day 1

  • Pain Scores at Rest and with Movement

    2, 4, 6, 12, 24, 36 and 48 hours postoperatively.

  • Postoperative Nausea and Vomiting

    2, 4, 6, 12, 24, 36 and 48 hours postoperatively.

Study Arms (2)

Group A

EXPERIMENTAL

Study participants will undergo intraoperative transversus abdominis plane (TAP) block with the syringe of medication supplied by the pharmacy using a syringe with attached spinal needle between the transversus abdominis and internal oblique. The spinal needle will be threaded horizontally and as far laterally at the superior aspect of the vertical axis of the incision as possible within this space and anesthetic will be injected after an initial pull back on the syringe to ensure there is no arterial exposure as per the following schedule: Weight \<70kg: Ropivacaine 75mg - 150 mg on each side (20mL ropivacaine 3.75mg/ml each side) Weight greater than or equal to 70kg: Ropivacaine 100mg - 200mg on each side (20mL ropivacaine 5mg/ml each side

Drug: RopivacaineProcedure: Transversus Abdominis Plane Block

Group B

PLACEBO COMPARATOR

Study participants will undergo intraoperative transversus abdominis plane (TAP) block with the syringe of medication supplied by the pharmacy using a syringe with attached spinal needle between the transversus abdominis and internal oblique. The spinal needle will be threaded horizontally and as far laterally at the superior aspect of the vertical axis of the incision as possible within this space and the placebo solution will be injected after an initial pull back on the syringe to ensure there is no arterial exposure as per the following schedule: Weight \<70kg: 20mL each side Weight greater than or equal to 70kg: 20mL each side

Other: PlaceboProcedure: Transversus Abdominis Plane Block

Interventions

RopivacaineDRUG
Group A
PlaceboOTHER
Group B
Transversus Abdominis Plane BlockPROCEDURE
Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Age≥18 years old and not pregnant
  • Must be able to provide informed consent - functional understanding of English
  • Undergoes exploratory laparotomy with midline abdominal incision

You may not qualify if:

  • History of substance abuse
  • History of chronic pain syndrome
  • Daily opioid use for more than 1 month
  • Patients considered to have chorioamnionitis at the time of cesarean surgery as determined by the attending physician
  • Prior abdominal surgery involving mesh or placement of an ostomy site as this may disrupt the plane in which the anesthetic may spread
  • Allergy to local anesthetics
  • History of cardiac arrhythmias or cardiac abnormalities
  • History of seizure disorder
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2015

First Posted

July 23, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

May 13, 2016

Record last verified: 2015-07

Locations

US(1)