SurgeryPhase 1/2NCT05257941
ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery
A Phase 1/2 study testing IT Injection and ESP Block in people with Surgery, run by Indiana University at 1 site in United States.
Trial summary
This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- IT Injection and ESP Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 29 Aug 2024
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital
- ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system)
- Age 18 to 80 years (male or female)
- BMI < 40kg/m2
- Desires regional anesthesia for postoperative pain control
Who cannot join
- Any contraindication for neuraxial analgesia or ESP block procedure
- Contraindications for neuraxial analgesia include: Elevated intracranial pressure (except in cases of pseudo-tumor cerebri), infection at the site of injection, lack of consent from the patient, patient refusal, true allergy to any drug used in the spine, and uncorrected hypovolemia.
- Contraindications for ESP block procedure include: Infection at the site of injection, patient refusal, true allergy to any of the drugs used in the block, and lack of patient consent.
- Any patient undergoing a laparoscopic abdominoperineal resection.
- Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex)
Show all 10Show fewer
- Takes over 30 mg of oral morphine equivalents daily
- Any history of substance abuse in the past 6 months
- End stage liver disease, end stage renal disease
- Body weight of < 50 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting
This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
Read the detailed description
All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken.
In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age.
In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron.
Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.
- Conditions
- Surgery
- Being tested
- IT Injection, ESP Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IT InjectionDrug
Also called Intrathecal (IT)
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
ESP BlockDrug
Also called Erector Spinae Plane Block (ESP)
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
| Study group | Role | What they receive |
|---|---|---|
| IT Injection | Active comparator | an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid Receives: Drug: IT Injection |
| ESP Block | Active comparator | an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. Receives: Drug: ESP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Cumulated Oral Morphine Equivalent (OME)
24 hour cumulated oral morphine consumption (OME)
Measured: 24 hours after surgery
Secondary outcomes (19)
Oral Morphine Equivalents (OME)
Oral Morphine Equivalents consumed
Measured: 1 hour after surgery
Oral Morphine Equivalents (OME)
Oral Morphine Equivalent consumption
Measured: 12 hours after surgery
Oral Morphine Equivalents (OME)
Oral Morphine Equivalent consumption
Measured: 24 hours after surgery
Oral Morphine Equivalents (OME)
Oral Morphine Equivalent consumption
Measured: 48 hours after surgery
Oral Morphine Equivalents (OME)
Oral Morphine Equivalent Consumption
Measured: 72 hours after surgery
Visual Analog Scale Pain Scores
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 1 hour after surgery
Visual Analog Scale Pain Scores
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 12 hours after surgery
Visual Analog Scale Pain Scores
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 24 hours after surgery
Visual Analog Scale Pain Scores
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 48 hours after surgery
Visual Analog Scale Pain Scores
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
Measured: 72 hours after surgery
First Ambulation
Time to patient first ambulation
Measured: Duration of hospital stay up to 72 hours
First Flatus
Time to first flatus
Measured: Duration of hospital stay up to 72 hours
Oral Liquid
Time to first oral liquid intake
Measured: Duration of hospital stay up to 72 hours
Oral Food
Time to first oral food intake
Measured: Duration of hospital stay up to 72 hours
Hospital Length of Stay
Amount of time each subject spends in the hospital before discharge
Measured: Duration of hospital stay up to 7 days
Patient's Satisfaction Scores
Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
Measured: 24 hours after surgery
Patient's Satisfaction Scores
Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
Measured: 48 hours after surgery
Number of Participants With Side Effects
Incidence of urinary retention, ileus, spinal headache, pruritis, respiratory depression, injection site infection, nerve damage, hematoma, pneumothorax, lower extremity weakness.
Measured: Duration of hospital stay up to 72 hours
Nausea
point in time of which had nausea
Measured: Duration of hospital stay up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start27 Jan 2022
- Primary completion26 Aug 2024
- Study completion29 Aug 2024
Why it stopped: study specific patients are now scheduled at another hospital for this procedure
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 (40)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy McCutchan, Indiana University
- Investigators
- Amy McCutchan, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257941
- Sponsor's protocol ID
- 12514
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2022
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
PubMed 18650627Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.
PubMed 24781574Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
PubMed 16775831Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
PubMed 19841366Khoo CK, Vickery CJ, Forsyth N, Vinall NS, Eyre-Brook IA. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Ann Surg. 2007 Jun;245(6):867-72. doi: 10.1097/01.sla.0000259219.08209.36.
PubMed 17522511McEvoy MD, Scott MJ, Gordon DB, Grant SA, Thacker JKM, Wu CL, Gan TJ, Mythen MG, Shaw AD, Miller TE; Perioperative Quality Initiative (POQI) I Workgroup. American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on optimal analgesia within an enhanced recovery pathway for colorectal surgery: part 1-from the preoperative period to PACU. Perioper Med (Lond). 2017 Apr 13;6:8. doi: 10.1186/s13741-017-0064-5. eCollection 2017.
PubMed 28413629Marret E, Remy C, Bonnet F; Postoperative Pain Forum Group. Meta-analysis of epidural analgesia versus parenteral opioid analgesia after colorectal surgery. Br J Surg. 2007 Jun;94(6):665-73. doi: 10.1002/bjs.5825.
PubMed 17514701Borzellino G, Francis NK, Chapuis O, Krastinova E, Dyevre V, Genna M. Role of Epidural Analgesia within an ERAS Program after Laparoscopic Colorectal Surgery: A Review and Meta-Analysis of Randomised Controlled Studies. Surg Res Pract. 2016;2016:7543684. doi: 10.1155/2016/7543684. Epub 2016 Aug 24.
PubMed 27642630Liu H, Hu X, Duan X, Wu J. Thoracic epidural analgesia (TEA) vs. patient controlled analgesia (PCA) in laparoscopic colectomy: a meta-analysis. Hepatogastroenterology. 2014 Jul-Aug;61(133):1213-9.
PubMed 25436285Merchea A, Lovely JK, Jacob AK, Colibaseanu DT, Kelley SR, Mathis KL, Spears GM, Huebner M, Larson DW. Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients. Surg Res Pract. 2018 Mar 1;2018:8174579. doi: 10.1155/2018/8174579. eCollection 2018.
PubMed 29687077Koning MV, Klimek M, Rijs K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal surgery: a meta-analysis, meta-regression, and trial sequential analysis. Br J Anaesth. 2020 Sep;125(3):358-372. doi: 10.1016/j.bja.2020.05.061. Epub 2020 Jul 11.
PubMed 32660719Day AR, Smith RV, Scott MJ, Fawcett WJ, Rockall TA. Randomized clinical trial investigating the stress response from two different methods of analgesia after laparoscopic colorectal surgery. Br J Surg. 2015 Nov;102(12):1473-9. doi: 10.1002/bjs.9936. Epub 2015 Sep 23.
PubMed 26395762Levy BF, Scott MJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011 Aug;98(8):1068-78. doi: 10.1002/bjs.7545. Epub 2011 May 17.
PubMed 21590762Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22.
PubMed 27005290
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting
- ClinicalTrials.gov ID
- NCT05257941
- Acronym / sponsor ID
- 12514
- Conditions
- Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study specific patients are now scheduled at another hospital for this procedure
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.
Detailed description
All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken.
In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age.
In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron.
Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IT Injection | Active comparator | Drug: IT Injectionan intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid |
| ESP Block | Active comparator | Drug: ESP Blockan erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital
- ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system)
- Age 18 to 80 years (male or female)
- BMI < 40kg/m2
- Desires regional anesthesia for postoperative pain control
Key exclusion criteria (10 listed)
- Any contraindication for neuraxial analgesia or ESP block procedure
- Any patient undergoing a laparoscopic abdominoperineal resection.
- Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex)
- Takes over 30 mg of oral morphine equivalents daily
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 |
|---|---|---|
| IT InjectionAlso: Intrathecal (IT)an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid | Drug | IT Injection |
| ESP BlockAlso: Erector Spinae Plane Block (ESP)an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back | Drug | ESP Block |
Primary outcome
24 Hour Cumulated Oral Morphine Equivalent (OME)
Time frame: 24 hours after surgery
24 hour cumulated oral morphine consumption (OME)
19 secondary outcomes
Oral Morphine Equivalents (OME)
Time frame: 1 hour after surgery
Oral Morphine Equivalents (OME)
Time frame: 12 hours after surgery
Oral Morphine Equivalents (OME)
Time frame: 24 hours after surgery
Oral Morphine Equivalents (OME)
Time frame: 48 hours after surgery
Oral Morphine Equivalents (OME)
Time frame: 72 hours after surgery
Visual Analog Scale Pain Scores
Time frame: 1 hour after surgery
Visual Analog Scale Pain Scores
Time frame: 12 hours after surgery
Visual Analog Scale Pain Scores
Time frame: 24 hours after surgery
Visual Analog Scale Pain Scores
Time frame: 48 hours after surgery
Visual Analog Scale Pain Scores
Time frame: 72 hours after surgery
First Ambulation
Time frame: Duration of hospital stay up to 72 hours
First Flatus
Time frame: Duration of hospital stay up to 72 hours
Oral Liquid
Time frame: Duration of hospital stay up to 72 hours
Oral Food
Time frame: Duration of hospital stay up to 72 hours
Hospital Length of Stay
Time frame: Duration of hospital stay up to 7 days
Patient's Satisfaction Scores
Time frame: 24 hours after surgery
Patient's Satisfaction Scores
Time frame: 48 hours after surgery
Number of Participants With Side Effects
Time frame: Duration of hospital stay up to 72 hours
Nausea
Time frame: Duration of hospital stay up to 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18650627Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 24781574Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.
- Background: PubMed 16775831Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
- Background: PubMed 19841366Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
- Background: PubMed 17522511Khoo CK, Vickery CJ, Forsyth N, Vinall NS, Eyre-Brook IA. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Ann Surg. 2007 Jun;245(6):867-72. doi: 10.1097/01.sla.0000259219.08209.36.
- Background: PubMed 28413629McEvoy MD, Scott MJ, Gordon DB, Grant SA, Thacker JKM, Wu CL, Gan TJ, Mythen MG, Shaw AD, Miller TE; Perioperative Quality Initiative (POQI) I Workgroup. American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on optimal analgesia within an enhanced recovery pathway for colorectal surgery: part 1-from the preoperative period to PACU. Perioper Med (Lond). 2017 Apr 13;6:8. doi: 10.1186/s13741-017-0064-5. eCollection 2017.
- Background: PubMed 17514701Marret E, Remy C, Bonnet F; Postoperative Pain Forum Group. Meta-analysis of epidural analgesia versus parenteral opioid analgesia after colorectal surgery. Br J Surg. 2007 Jun;94(6):665-73. doi: 10.1002/bjs.5825.
- Background: PubMed 27642630Borzellino G, Francis NK, Chapuis O, Krastinova E, Dyevre V, Genna M. Role of Epidural Analgesia within an ERAS Program after Laparoscopic Colorectal Surgery: A Review and Meta-Analysis of Randomised Controlled Studies. Surg Res Pract. 2016;2016:7543684. doi: 10.1155/2016/7543684. Epub 2016 Aug 24.
- Background: PubMed 25436285Liu H, Hu X, Duan X, Wu J. Thoracic epidural analgesia (TEA) vs. patient controlled analgesia (PCA) in laparoscopic colectomy: a meta-analysis. Hepatogastroenterology. 2014 Jul-Aug;61(133):1213-9.
- Background: PubMed 29687077Merchea A, Lovely JK, Jacob AK, Colibaseanu DT, Kelley SR, Mathis KL, Spears GM, Huebner M, Larson DW. Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients. Surg Res Pract. 2018 Mar 1;2018:8174579. doi: 10.1155/2018/8174579. eCollection 2018.
- Background: PubMed 32660719Koning MV, Klimek M, Rijs K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal surgery: a meta-analysis, meta-regression, and trial sequential analysis. Br J Anaesth. 2020 Sep;125(3):358-372. doi: 10.1016/j.bja.2020.05.061. Epub 2020 Jul 11.
- 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.
Amy McCutchan, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IT Injection and ESP Block in people with Surgery, run by Indiana University 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 10 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: stopped early, as of the sponsor's last update on 2 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 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?
24 Hour Cumulated Oral Morphine Equivalent (OME) (time frame: 24 hours after surgery). 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 NCT05257941, which also lists 40 linked publications.
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 2 Mar 2026.