Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain

NCT01731782 | Completed Results DMC

• 1 other identifier: 02-12-03
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Patients experience pain after surgery mostly from their abdominal wounds, even when those wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases stress response and might improve the outcome of the surgery. Local anesthesia (which is a numbing agent given directly at the site of pain via a needle) is given to decrease the pain that is felt after surgery and decrease the need for strong pain medications which can have negative side effects. One promising way to give local pain medication is called the "transversus abdominis plane" or TAP block. This method works by directly blocking the nerves in the abdomen that are the cause of the pain patients feel in their incision after surgery. This is done by injecting a numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located that cause pain. In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling in a particular nerve. Patients will be randomized (like a flip of a coin) to receive either a normal saline injection or the bupivacaine injection. The purpose of this study will be to prove the effectiveness of local anesthetic given via a TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing postoperative nausea and vomiting and improve surgical outcomes such as hospital length of stay in laparoscopic colorectal surgery.

Conditions

Colorectal Disease

Keywords

colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain as Measured by Pain Score

  Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain

  up to 10 days

Secondary Outcomes (1)

• Percent of Analgesics Used as Measured by Patient Report

  Up to 30 days after surgery

Other Outcomes (3)

• Number of Nausea/Vomiting Episodes

  up to 10 days

• Length of Hospital Stay

  up to 10 days

• Day of Return of Bowel Function

  daily after surgery until discharge up to 10 days

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml

Drug: bupivacaine

normal saline

PLACEBO COMPARATOR

Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine

Drug: normal saline placebo (for bupivacaine)

Interventions

bupivacaine DRUG

Also known as: Marcaine

bupivacaine

normal saline placebo (for bupivacaine) DRUG

Normal saline to mimic bupivacaine

normal saline

Eligibility Criteria

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

You may qualify if:

• Subjects who have benign or malignant colonic or rectal disease that are being scheduled for laparoscopic colorectal resection.
• Subjects who are 18 years of age and older
• Subjects of either sex
• Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

You may not qualify if:

• Subjects who undergo conversion to the open approach will be excluded from the analysis, as the block will be given at the end of the procedure and is being evaluated for laparoscopic cases.
• Subjects who are pregnant.
• Subjects with a medical condition that may interfere with the use of the study medication Bupivicaine.
• Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Conor Delaney
• Organization: Cleveland Clinic Florida Region

DELANEC@ccf.org

954-659-6001

Study Officials

• Conor P Delaney, MD.,PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: November 22, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-09

Locations

US (1)