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Colorectal SurgeryPhase 4NCT04752033

Intrathecal Opioids for Colorectal Resection

A Phase 4 study testing Morphine and Hydromorphone in people with Colorectal Surgery and Pain, Postoperative, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is being done to determine the optimal dose of spinal morphine and hydromorphone in patients undergoing minimally-invasive (i.e., surgery performed through small entry sites and using cameras) colorectal surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Morphine and Hydromorphone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
10 Mar 2021to 17 Feb 2023
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III.
  • Undergoing colorectal minimally invasive surgery (MIS).
  • Age between 18 and 75 years of age.
  • Body mass index (BMI) between 18.5 and 40.
  • Ability to understand and read English.

Who cannot join

  • Not able or unwilling to sign consent.
  • Patients undergoing ileostomy closure.
  • Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery
  • Patients with chronic pain, requiring daily opioid use at the time of surgery.
  • Patient intolerant or allergic to opioids, NSAIDs, or acetaminophen.
  • Patients requiring emergent surgery.
Show all 9Show fewer
  • Any contraindication to neuraxial anesthesia (coagulopathy, localized infection at the site of injection, pre-existing spinal pathology, or peripheral neuropathy).
  • Any patients currently receiving any anticoagulation medication other than aspirin and who have not discontinued the medication per American Society of Regional Anesthesia anticoagulation guidelines22, and/or an abnormal INR.
  • Patients with hepatic or renal insufficiency in as much as the patient is not a candidate for acetaminophen or NSAIDs, respectively.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Intrathecal Opioids for Pain Control After Colorectal Resection: Determining the Optimal Dose

This research study is being done to determine the optimal dose of spinal morphine and hydromorphone in patients undergoing minimally-invasive (i.e., surgery performed through small entry sites and using cameras) colorectal surgery.

Read the detailed description

Intrathecal (IT) opioids have been established as a safe and efficacious modality to treat postoperative pain. In the setting of colorectal surgery, studies have shown that intrathecal opioids together with multimodal analgesic regimens provide pain relief superior to multimodal analgesia alone. Furthermore, in the setting of multimodal analgesia, IT opioids also appear to be equianalgesic to epidural analgesia while conferring an improved safety profile. As a result, many institutions have incorporated intrathecal opioids into their Enhanced Recovery after Surgery (ERAS) pathways.

While morphine has traditionally been considered the "gold standard" in IT opioid therapy for postsurgical pain, hydromorphone has been gaining popularity as an alternative. The doses ranging between 0.005 mg to 0.25 mg for hydromorphone12-15 and 0.05 mg to 0.625 mg (with doses as high as 10 mcg/kg in the setting of cardiac surgery) for morphine has been found to be efficacious in this patient population. However, increasing opioid doses are associated with increased incidence of adverse effects. A meta-analysis reviewing twenty-eight studies which investigated intrathecal morphine versus placebo demonstrated moderate increases in the incidences of pruritus, nausea and vomiting. In fact, the incidence of nausea with IT morphine has been reported to be 33%. While hydromorphone is similar chemically to morphine, it is metabolized differently. Differences in pharmacokinetics may allow for differences in side effect profiles. Hydromorphone is more lipid soluble than morphine. This decreases its spread within the intrathecal space and enhances its penetration into the dorsal horn of the spinal cord where interactions with opioid receptors occur. Some studies (performed in the women undergoing cesarean delivery) have also found that hydromorphone causes less nausea and pruritus than morphine, while others have not.

Despite the widespread use of IT hydromorphone and morphine for pain after colorectal surgery, the optimal dose for neither drug has been established in prospective trials. The investigators have previously performed a dose-finding study of IT hydromorphone and morphine in women undergoing cesarean delivery. Briefly, 80 parturients scheduled for elective cesarean delivery were randomized to receive IT morphine or IT hydromorphone at a dose determined using up-down sequential allocation with a biased-coin design to determine ED90, which was found to be 75 mcg for IT hydromorphone and 150 mcg for IT morphine. The follow-up study performed by the investigators also found no differences in adverse effects or efficacy between the drugs. The results from the obstetric population, however, cannot be directly translated to the colorectal surgery population due to pharmacodynamic and pharmacokinetics differences related to the pregnancy, age, presence of comorbidities, differences in surgical techniques, and co-administration of IT local anesthetic.

This study applies the methodology the investigators have previously used in the obstetric population to the patients undergoing colorectal resection and aims to identify the optimal dose of IT hydromorphone and morphine that provides good pain relief without causing significant side effects. Secondarily, the investigators will compare each drug at its optimal dose in terms of opioid consumption and side effects. Based on their prior findings, the investigators hypothesize that the optimal dose of intrathecal hydromorphone will be 75 mcg and the optimal dose of intrathecal morphine will be 150 mcg. Additionally, the investigators hypothesize that exploratory findings comparing the two drugs at their optimal doses will show no difference in the incidence of adverse effects.

Being tested
Morphine, Hydromorphone
Keywords
Intrathecal, Morphine, Hydromorphone, Dose Finding
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MorphineDrug

    Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.

  • HydromorphoneDrug

    Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.

Study groups in NCT04752033
Study groupRoleWhat they receive
MorphineExperimentalSubjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm
Receives: Drug: Morphine
HydromorphoneExperimentalSubjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm
Receives: Drug: Hydromorphone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Control

    Failure was reported as a pain score of over 4/10 on a Numeric Rating Scale (NRS), scale range 0-10, 0 being no pain and 10 being the worst pain imaginable

    Measured: 12 hours after intrathecal (IT) drug administration

Secondary outcomes (4)
  1. Postoperative Pain Control

    Reported as Numeric Rating Scale (NRS), scale range 0-10, 0 being no pain and 10 being the worst pain imaginable.

    Measured: 24 hours after IT drug administration

  2. Presence and Severity of Opioid-related Side Effects at Their Highest Doses

    Nausea and vomiting, pruritus, sedation, respiratory depression. The ordinal subjective scale of mild, moderate, and severe will be used.

    Measured: 12 and 24 hours after IT drug administration

  3. Overall Benefits of Analgesia Score (OBAS)

    OBAS is a validated measure incorporating both effectiveness of pain control and unwanted effects related to analgesic treatment. The scale ranges from 0 to 24, with higher the score, worse the pain control.

    Measured: 12 and 24 hours after highest IT drug administration

  4. Quality of Recovery (QoR) 15 Score

    QoR 15 score is a multidimensional, valid, reliable, responsive, and easy-to-use method of measuring quality in patients' postoperative recovery. The scale ranges from 0 to 150, with higher the score, the better the recovery is.

    Measured: 24 hours after IT drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start10 Mar 2021
  3. Primary completion17 Feb 2023
  4. Study completion17 Feb 2023

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose Finding Study Utilizing Sequential Up and Down Method Using Biased Coin Design
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752033
Sponsor's protocol ID
20-009205
Status last verified
Mar 2024
First submitted
28 Jan 2021
Last updated
26 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vinsard PA, Pleticha J, Sharpe EE, Panchamia JK, Olsen DA, Sviggum HP, Shawki SF, Behm KT, Larson DW, LeMahieu AM, Niesen AD, Amundson AW. A Prospective Randomized Dose-Finding Study of Intrathecal Opioids for Postoperative Analgesia After Minimally Invasive Colorectal Operation. Mayo Clin Proc Innov Qual Outcomes. 2025 Mar 3;9(2):100600. doi: 10.1016/j.mayocpiqo.2025.100600. eCollection 2025 Apr.

    PubMed 40114986

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Morphine and Hydromorphone in people with Colorectal Surgery and Pain, Postoperative, run by Mayo Clinic 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 9 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 26 Mar 2024. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 26 Mar 2024). 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?

Postoperative Pain Control (time frame: 12 hours after intrathecal (IT) drug administration). 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 NCT04752033, 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 26 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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