Colon CancerTAPNCT02591407
Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery
A study testing TAP Block and Continuous Epidural Analgesia in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- What is being tested?
- TAP Block and Continuous Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Being tested
- TAP Block, Continuous Epidural Analgesia
- Keywords
- Continuous Epidural Analgesia, Transversus Abdominis Plane block
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockProcedure or surgery
Also called Exparel
This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
Continuous Epidural AnalgesiaProcedure or surgery
Epidural catheter placed prior to the operation in the standard fashion
| Study group | Role | What they receive |
|---|---|---|
| TAP Block- Exparel | Active comparator | Transversus abdominis plane block utilizing the medication Exparel® Receives: Procedure: TAP Block |
| Continuous Epidural Analgesia | Active comparator | Continuous Epidural Analgesia Receives: Procedure: Continuous Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Mean Numeric Pain Scale.
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.
Measured: Post-operative day 0,1,2,3
Overall Benefits of Analgesia Score (OBAS)
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.
Measured: Post-operative day 0,1,2,3
Secondary outcomes (5)
Patient Use of Narcotic Analgesia Post-op Day 0
Patient use of narcotic analgesia post-operative day 0 including Fentanyl from epidural
Measured: Post-operative day 0
Patient Use of Narcotic Analgesia Post-operative Day 0
Patient use of narcotic analgesia post operative day 0 excluding Fentanyl from epidural.
Measured: Post-operative day 0
Patient Use of Narcotic Analgesia Post-operative Day 3
Patient use of narcotic analgesia post-operative day 3 including Fentanyl from epidural
Measured: Post-operative day 3
Patient Use of Narcotic Analgesia Post-operative Day 1
Patient use of narcotic analgesia post operative day 1 including Fentanyl from epidural
Measured: Post-operative day 1
Patient Use of Narcotic Analgesia Post-operative Day 2
Patient use of narcotic analgesia post operative day 2 including Fentanyl from epidural
Measured: Post-operative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start12 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert K Cleary, Trinity Health Michigan
- Investigators
- Robert K Cleary, MD, Principal investigator, Saint Joseph Mercy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591407
- Sponsor's protocol ID
- HSR 15-1618
- Acronym
- TAP
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2015
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.
PubMed 30192328
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02591407
- Acronym / sponsor ID
- TAP / HSR 15-1618
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Keywords
- Continuous Epidural Analgesia, Transversus Abdominis Plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Trinity Health MichiganUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block- Exparel | Active comparator | Procedure: TAP BlockTransversus abdominis plane block utilizing the medication Exparel® |
| Continuous Epidural Analgesia | Active comparator | Procedure: Continuous Epidural AnalgesiaContinuous Epidural Analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP BlockAlso: ExparelThis is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles | Procedure or surgery | TAP Block- Exparel |
| Continuous Epidural AnalgesiaEpidural catheter placed prior to the operation in the standard fashion | Procedure or surgery | Continuous Epidural Analgesia |
Primary outcome
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.
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. 1. 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). 7. 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.
5 secondary outcomes
Patient Use of Narcotic Analgesia Post-op Day 0
Time frame: Post-operative day 0
Patient Use of Narcotic Analgesia Post-operative Day 0
Time frame: Post-operative day 0
Patient Use of Narcotic Analgesia Post-operative Day 3
Time frame: Post-operative day 3
Patient Use of Narcotic Analgesia Post-operative Day 1
Time frame: Post-operative day 1
Patient Use of Narcotic Analgesia Post-operative Day 2
Time frame: Post-operative day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30192328Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.
- American Society of Colon and Rectal SurgeonsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert K Cleary, MD principal investigator
Saint Joseph Mercy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block and Continuous Epidural Analgesia in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Mean Numeric Pain Scale. (time frame: Post-operative day 0,1,2,3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.