Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions

NCT02447965 | Terminated DMC

• 1 other identifier: 203780
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Rectus Sheath Blocks; Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.

  The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Bupivacaine DRUG

Using ultrasound guidance bupivacaine will be injected into the active group's rectus abdominis sheath.

Also known as: Marcaine

Bupivacaine

Normal Saline DRUG

Using ultrasound guidance normal saline will be injected into the placebo group's rectus abdominis sheath.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (3)

• 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.

  PMID: 23984583 BACKGROUND

• 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.

  PMID: 24664392 BACKGROUND

• 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.

  PMID: 25289373 BACKGROUND

MeSH Terms

Conditions

Hernia; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrew G Cain, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 19, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)