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Completed

NCT Number: NCT02591407

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Diverticulosis Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticulosis, Colonic Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block

Procedure

This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles

Other names: Exparel

Continuous Epidural Analgesia

Procedure

Epidural catheter placed prior to the operation in the standard fashion

Primary outcomes

  1. Post-operative Mean Numeric Pain Scale.

    Time frame: Post-operative day 0,1,2,3

    Measured by patient completing the Numeric Pain Scale (NPS) on post-operative day 0,1,2,3. Numeric Pain Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

    Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.

  2. Overall Benefits of Analgesia Score (OBAS)

    Time frame: Post-operative day 0,1,2,3

    Measured by the patient completing the OBAS survey on postoperative days 0,1,2,3. The OBAS is a multi-dimensional quality assessment instrument to measure patients' benefit from postoperative pain therapy.

    • Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2-6. Grade any distress and bother from vomiting in the past 24 h (0=not at all to 4=very much: same scale for remaining Qs about itching, sweating, freezing, dizziness on the scale).
    • Rate your satisfaction with your pain treatment on a scale between 0=not at all and 4= very much

    To calculate the OBAS score, compute the sum of scores in items 1-6 and add the '4-(score in item 7)'. The range of scores is from 0 (best) to 28 (worst).

    Data from all the specified time points above (post-operative day 0,1,2,3) was averaged into a single value.

Secondary outcomes

  1. Patient Use of Narcotic Analgesia Post-op Day 0

    Time frame: Post-operative day 0

    Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural

  2. Patient Use of Narcotic Analgesia Post-operative Day 0

    Time frame: Post-operative day 0

    Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural.

  3. Patient Use of Narcotic Analgesia Post-operative Day 3

    Time frame: Post-operative day 3

    Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural

  4. Patient Use of Narcotic Analgesia Post-operative Day 1

    Time frame: Post-operative day 1

    Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural

  5. Patient Use of Narcotic Analgesia Post-operative Day 2

    Time frame: Post-operative day 2

    Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural

Sponsors and collaborators

Lead sponsor

Trinity Health Michigan

Other

Registry information

Official study title

A Prospective Randomized Clinical Trial Comparing the Transversus Abdominis Plane Block (TAP) Versus Epidural Anesthesia For Enhanced Recovery Pathway Perioperative Management of Pain in Elective Colorectal Surgery

Acronym: TAP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2015
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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