NCT07846657

Brief Summary

Dr. Parker Merrill (anesthesiologist) and Dr. Chris Neal (neurosurgeon) are working on a research study comparing two methods of pain control for patients having spinal fusion surgery. We are looking for English-speaking patients between 18 and 70 years old who are scheduled for 1-2 level lumbar spine fusion surgery. Participants in this study will either get morphine injected during surgery (current pain treatment) or morphine and another drug, clonidine. There is an equal chance of getting the two treatment options. No matter which group you are assigned to, you will be provided with additional pain medication if needed after your surgery. You may not directly benefit from participating in this study, but you might have an improvement in your pain after surgery. You will also be helping researchers and doctors find better pain control options for future patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
16mo left

Started Oct 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jan 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Lumbar Fusion Surgery

Keywords

lumbar fusionintrathecal morphineintrathecal clonidine

Outcome Measures

Primary Outcomes (1)

  • Post-operative opioid consumption

    Post-operative opioid consumption measured as morphine milligram equivalents (MME)

    24 hours post-op

Secondary Outcomes (2)

  • Pain scores

    72 hours post-op

  • Post-operative opioid consumption

    72 hours post-op

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

Participants in this group will receive the current standard of care.

Drug: Intrathecal Morphine

Intrathecal Morphine + Intrathecal Clonidine

EXPERIMENTAL

Participants in this group will receive the experimental treatment; the standard of care with the addition of 75 mcg of intrathecal clonidine.

Drug: Intrathecal Morphine + Intrathecal Clonidine

Interventions

Intrathecal MorphineDRUG

Participants in this group will receive the standard of care; 150 mcg of intrathecal morphine

Intrathecal Morphine
Intrathecal Morphine + Intrathecal ClonidineDRUG

Participants in the intervention group will receive the standard of care (150 mcg of intrathecal morphine) with the addition of 75 mcg of clonidine.

Intrathecal Morphine + Intrathecal Clonidine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Scheduled for 1-2 level lumbar fusion
  • Expected post-operative inpatient stay of at least 24 hours
  • ASA I-III
  • English speaking

You may not qualify if:

  • Substance use disorder
  • Chronic pain (opioid use of 90 MME daily prior to surgery)
  • BMI \> 40
  • Allergies to clonidine or morphine
  • Emergent surgery
  • Coagulopathy (INR \>1.5)
  • Platelet count \<80
  • Significant cardiovascular disease
  • baseline systolic blood pressure \<100
  • Patients on clonidine prior to surgery
  • Patients scheduled for a revision surgical procedure
  • Patients who are unable to give informed consent
  • Pregnant patients
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MaineHealth Maine Medical Center-Portland

Portland, Maine, 04102, United States

Location

Study Officials

  • Parker Merrill, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janelle Research Coordinator

CONTACT

207-662-2862janelle.richard@mainehealth.org

Parker Merrill, MD

CONTACT

617-221-3028Parker.merrill@spectrumhcp.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Deidentified IPD relating to primary and secondary outcomes will be made available following IRB approval and execution of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Requests can be submitted 9 months after publication and will be available for up to 24 months.
Access Criteria
Data obtained through this study may be provided to qualified researchers with academic interest. Data will be deidentified, and access requires approval of a research proposal, execution of a Data Sharing Agreement, and IRB approval. Requests can be submitted starting 9 months after publication and will be available for up to 24 months

Locations

US(1)