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Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP) (GYNTAP)

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Placebo
Transversus Abdominis Plane Block
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Level of Nerve (Dermatome) Block
The investigator will complete dermatomal assessments at the specified time frames by using a stimulus in the area of the transversus abdominis plane block to determine the effectiveness of the block.
Pain Scores at Rest and with Movement
Pain severity will be measured using a validated Numerical Rating Scale with 0cm=no pain and 10cm=worst pain imaginable.
Postoperative Nausea and Vomiting
Nausea will be measured using a validated postoperative nausea and vomiting scale known as the Impact Scale.

Full Information

First Posted
June 11, 2015
Last Updated
May 12, 2016
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02506855
Brief Title
Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)
Acronym
GYNTAP
Official Title
Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP): Modifying an Existing Technique for Ease of Administration and Increased Accuracy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The investigator decided not to continue the study.
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is a prospective, randomized blinded study that investigates the efficacy of a transversus abdominis plane block under direct view. In this pilot study involving gynecologic patients undergoing open (abdominal wall incision either vertically or horizontally) hysterectomy or other related gynecologic surgery, the investigators will use ropivacaine versus saline for the placebo control group, which in both groups involves injection of agent directly into the appropriate fascial layers prior to abdominal wall closure. Efficacy is to be assessed via measurement of pain scores, nausea and vomiting, and opioid consumption in both participant groups. The number of dermatomes which are blocked in both participant groups during the first 24 hours following surgery will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Primary Outcome Measure Information:
Title
Milligrams of Diludid Consumption During First 48 hours Following Surgery
Description
The amount of diludid received per participant will be recorded from participant medication record at the specified time frame.
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Level of Nerve (Dermatome) Block
Description
The investigator will complete dermatomal assessments at the specified time frames by using a stimulus in the area of the transversus abdominis plane block to determine the effectiveness of the block.
Time Frame
4hrs postoperative and on postoperative day 1
Title
Pain Scores at Rest and with Movement
Description
Pain severity will be measured using a validated Numerical Rating Scale with 0cm=no pain and 10cm=worst pain imaginable.
Time Frame
2, 4, 6, 12, 24, 36 and 48 hours postoperatively.
Title
Postoperative Nausea and Vomiting
Description
Nausea will be measured using a validated postoperative nausea and vomiting scale known as the Impact Scale.
Time Frame
2, 4, 6, 12, 24, 36 and 48 hours postoperatively.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

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Intraoperative Transversus Abdominis Plane Block for Gynecologic Surgery (GYNTAP)

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