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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01731782
First received: October 19, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Colorectal Disease
Drug: bupivacaine
Drug: normal saline placebo (for bupivacaine)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of a TAP Block as Part of an Enhanced Recovery Pathway in Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-blinded Multi-institution Trial

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Evaluate the improvement of postoperative pain [ Time Frame: Daily after surgery up until discharge up to 10 days ] [ Designated as safety issue: No ]
    Daily pain scores while in the hospital


Secondary Outcome Measures:
  • evaluate the use of analgesics [ Time Frame: daily until 30 days after surgery ] [ Designated as safety issue: No ]
    log the daily use of analgesics (PCA and oral) in morphine equivalents and opioids used


Other Outcome Measures:
  • evaluate postoperative nausea and vomiting [ Time Frame: daily after surgery until discharge up to 10 days ] [ Designated as safety issue: No ]
    daily post-operative nausea/vomiting scores and log the daily use of antiemetics

  • length of hospital stay [ Time Frame: admission until day of discharge up to 10 days ] [ Designated as safety issue: No ]
    document the length of the hospital stay by the number of days from admission until discharge

  • Day of return of bowel function [ Time Frame: daily after surgery until discharge up to 10 days ] [ Designated as safety issue: No ]
    Log the day bowel function returns by day postoperative that flatus returns and has first stool

  • Evaluate post operative occurence of ileus [ Time Frame: daily after surgery until discharge up to 10 days ] [ Designated as safety issue: No ]
    Measure post operative complications, including ileus (defined as reduction in diet and placement of a nasogastric tube)

  • Readmission to the hospital [ Time Frame: Discharge up to 30 days after surgery ] [ Designated as safety issue: No ]
    Note and follow any readmission to the hospital after surgery for up to 30 days


Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bupivacaine
bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml
Drug: bupivacaine
Other Name: Marcaine
Placebo Comparator: normal saline
Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine
Drug: normal saline placebo (for bupivacaine)
Normal saline to mimic bupivacaine

Detailed Description:

Using standard surgical procedures, the surgeon will proceed with the planned laparoscopic surgery. All procedures will be done by straight laparoscopic technique according to standard of care. At the completion of the procedure, and under laparoscopic control, patients will have a TAP block placed by the attending surgeon. The clinical research nurse involved in the research will prep the solution to be injected and the surgeon will be blinded as to whether the patient will be receiving normal saline or Marcaine in the TAP blocks. The block will be administered between the costal margin and iliac crest in the anterior axillary line. A Braun Stimuplex A insulated needle (80 mm 21 gauge) with 0.5 mL/kg solution (max of 30 ml) is passed through the skin, and then continued until two distinct "pops" are felt, which indicates the needle piercing each of the two fascial layers. The needle is then deemed to be in the inter-muscular plane between internal oblique and transversus abdominis muscles respectively, to target the spinal nerves in this plane. The laparoscope will be visualizing for the needle tip to ensure that it does not penetrate the peritoneum or inject pre-peritoneally. The local anesthetic is infiltrated in two separate injections into the same plane on each side. If a sub-peritoneal bleb is seen to be raised by the laparoscope, then the needle will be withdrawn slightly. Two thirds of the solution is injected, and the needle is withdrawn 5 mm and the remaining solution is injected. If injecting in the correct plane, then a smooth raised area of fluid, covered by transversus will be seen via the laparoscope. This procedure is repeated on the patients other side, to complete a bilateral block. Depending on their randomization, patients will receive one of the following solutions:

Group A: Represents the control group and will receive 0.5 ml/kg of 0.9% normal saline for a maximum of 30 ml.

Group B: Represents the experimental group and will receive 0.5 ml/kg of 0.25% Marcaine (bupivacaine) for a maximum of 30 ml.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Subjects who are pregnant.
  3. Subjects with a medical condition that may interfere with the use of the study medication Bupivicaine.
  4. Subjects who have another condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731782

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Conor P Delaney, MD.,PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Conor Delaney, MD, PhD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01731782     History of Changes
Other Study ID Numbers: 02-12-03
Study First Received: October 19, 2012
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
colorectal surgery

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014