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Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions

Primary Purpose

Hernia, Pain, Postoperative, Abdominal Wall Relaxation After Rectus Sheath Block

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Normal Saline
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hernia focused on measuring Rectus Sheath Blocks, Abdominal Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Scheduled to undergo an abdominal procedure with a periumbilical or midline incision above the umbilicus
  • Age ≥ 18 years.
  • American Society of Anesthesiologists physical status class 1 to 3

Exclusion Criteria:

  • Known coagulopathy
  • Preexisting muscular disease
  • Medical conditions contraindicated to bupivacaine, succinylcholine or other medication used in the study

Sites / Locations

  • Univerisity of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Normal Saline

Arm Description

Will have 20ml of bupivacaine injected into each rectus sheath.

Will have 20ml of normal saline injected into each rectus sheath.

Outcomes

Primary Outcome Measures

Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2015
Last Updated
July 19, 2017
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02447965
Brief Title
Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions
Official Title
Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions: A Prospective Randomized Double-Blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
difficult recruitment
Study Start Date
January 1, 2016 (undefined)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.
Detailed Description
The patients in the active group will be taken to the operating room and standard american society of anesthesiologists monitors will be applied. After induction of general anesthesia, the ultrasonographic anatomy of the umbilical region will be studied in each patient. The probe will be adjusted until optimum view of both rectus abdominis muscles, their sheaths and surrounding structures are identified. Once the umbilical region anatomy has been identified the puncture sites will be determined. The puncture sites will be aseptically prepped, the ultrasound probed will be covered with a sterile tegaderm, and sterile ultrasound gel will be used on the field. A 21-g EchoStim echogenic needle will be used. The needle will be inserted in the long axis parallel to the ultrasound probe. The needle will be advanced carefully until the needle tip is seen between the posterior aspect of the rectus muscle and its sheath. After a confirmed negative aspiration, 15 ml of 0.25% bupivacaine will be inserted in 2 ml increments, aspirating in between. The placebo group will have the exact same procedure performed except 15 ml of normal saline will be injected in each rectus sheath instead of 0.25% bupivacaine. For all patients, when the block has been completed the surgery team will then prep the patient and proceed with the planned operation. The surgery staff and anesthesia providers taking care of the patient in the operating room will be unaware of the patient's group. At this point, all patients will be treated exactly the same. For intubation purposes, all patients will only receive succinylcholine. After intubation, elimination of the succinylcholine dose will be determined using a twitch monitor on the ulnar nerve. If at any point during the surgery, the surgery team needs more muscle relaxation then the anesthesia staff will give appropriate medications. The first step will be to administer propofol 50mg IV, if hemodynamics allow, and to verify that the patient has 1.0-1.2 minimum alveolar concentration (MAC) of volatile anesthetic. If the patient is not at 1.0 MAC, then the volatile anesthetic should be increased. If this does not provide sufficient relaxation, then a nondepolarizing muscle relaxant will be given in 10mg increments titrated to a train of four of 2 twitches at the ulnar nerve. All patients will receive ofirmev and fentanyl in the operating room for pain control. Ofirmev 1000mg will be given pre-incision to each patient and 1.5 mcg/kg loading dose of fentanyl will be given to each patient. Fentanyl will be redosed in 50mcg increments for a 20% increase in blood pressure or heart rate above preinduction values that is sustained for 5 minutes despite an adequate depth of anesthesia, defined as 1 MAC or greater.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Pain, Postoperative, Abdominal Wall Relaxation After Rectus Sheath Block
Keywords
Rectus Sheath Blocks, Abdominal Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Will have 20ml of bupivacaine injected into each rectus sheath.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Will have 20ml of normal saline injected into each rectus sheath.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Using ultrasound guidance bupivacaine will be injected into the active group's rectus abdominis sheath.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Using ultrasound guidance normal saline will be injected into the placebo group's rectus abdominis sheath.
Primary Outcome Measure Information:
Title
Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.
Time Frame
The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo an abdominal procedure with a periumbilical or midline incision above the umbilicus Age ≥ 18 years. American Society of Anesthesiologists physical status class 1 to 3 Exclusion Criteria: Known coagulopathy Preexisting muscular disease Medical conditions contraindicated to bupivacaine, succinylcholine or other medication used in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew G Cain, M.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univerisity of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23984583
Citation
Kimura F, Oishi M, Yakoshi C, Ogasawara C, Ishihara H, Hirota K. [Rectus sheath block and transversus abdominis plane block for a patient with Lambert-Eaton myasthenic syndrome undergoing low anterior resection]. Masui. 2013 Aug;62(8):989-91. Japanese.
Results Reference
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PubMed Identifier
24664392
Citation
Quek KH, Phua DS. Bilateral rectus sheath blocks as the single anaesthetic technique for an open infraumbilical hernia repair. Singapore Med J. 2014 Mar;55(3):e39-41. doi: 10.11622/smedj.2014042.
Results Reference
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PubMed Identifier
25289373
Citation
Bashandy GM, Elkholy AH. Reducing postoperative opioid consumption by adding an ultrasound-guided rectus sheath block to multimodal analgesia for abdominal cancer surgery with midline incision. Anesth Pain Med. 2014 Aug 10;4(3):e18263. doi: 10.5812/aapm.18263. eCollection 2014 Aug.
Results Reference
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Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions

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