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Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery (TAP)

T

Trinity Health Michigan

Status

Completed

Conditions

Colonic Diverticulosis
Colon Cancer
Rectal Cancer

Treatments

Procedure: TAP Block
Procedure: Continuous Epidural Analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02591407
HSR 15-1618

Details and patient eligibility

About

The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.

Full description

Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery.

This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum;
  • Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic);
  • Patients > 18 years of age;
  • Able to provide informed written consent
  • Patients capable of completing questionnaires at the time of consent

Exclusion criteria

  • Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl;
  • Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated International Normalized Ratio (INR), anticoagulation, patient refusal, etc) or TAP block (patient refusal);
  • Urgent or emergent surgery precluding epidural catheter placement or TAP block;
  • Systemic Infection contraindicating epidural catheter placement or TAP block;
  • Unwillingness to participate in follow up assessments;
  • Prisoners
  • Pregnant women

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

TAP Block- Exparel
Active Comparator group
Description:
Transversus abdominis plane block utilizing the medication Exparel®
Treatment:
Procedure: TAP Block
Continuous Epidural Analgesia
Active Comparator group
Description:
Continuous Epidural Analgesia
Treatment:
Procedure: Continuous Epidural Analgesia

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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