Intrathecal Opioids for Colorectal Resection

NCT04752033 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-009205
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Surgery; Pain, Postoperative; Analgesic, Opioid

Keywords

Intrathecal; Morphine; Hydromorphone; Dose Finding

Outcome Measures

Primary Outcomes (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

  12 hours after intrathecal (IT) drug administration

Secondary Outcomes (4)

• Postoperative Pain Control

  24 hours after IT drug administration

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

  12 and 24 hours after IT drug administration

• Overall Benefits of Analgesia Score (OBAS)

  12 and 24 hours after highest IT drug administration

• Quality of Recovery (QoR) 15 Score

  24 hours after IT drug administration

Study Arms (2)

Morphine

EXPERIMENTAL

Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm

Drug: Morphine

Hydromorphone

EXPERIMENTAL

Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm

Drug: Hydromorphone

Interventions

Morphine DRUG

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.

Morphine

Hydromorphone DRUG

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.

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 40114986 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Difficulties during patient selection as minimally invasive colorectal surgeries were performed as an outpatient basis negating the use of IT opioids. This issue prolonged patient recruitment.

Results Point of Contact

• Title: Dr. Joseph Pleticha
• Organization: Mayo Clinic

Pleticha.joseph@mayo.edu

5073588378

Study Officials

• Adam W Amundson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dose Finding Study Utilizing Sequential Up and Down Method Using Biased Coin Design

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 12, 2021
• Study Start: March 10, 2021
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)