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Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery

NCT ID: NCT05351229

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2026-09-01

Brief Summary

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VATS/RATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS/RATS. The optimal strategy for pain management has not been defined. In this randomized, placebo-controlled, double-blinded clinical investigation, investigators hypothesize that 5 mcg/kg intrathecal morphine will decrease postoperative analgesic consumption and reduce pain.

Detailed Description

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This is a randomized, placebo-controlled, double-blinded clinical trial. Patients will be randomized into one of two groups. Group A (Placebo, control group) will receive intrathecal sterile normal saline and Group B (Morphine group) will receive 5mcg/kg preservative free intrathecal morphine.

American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).

Patients will be followed up with a phone survey at 1 and 3 months after surgery to assess the presence, nature, and severity of chronic persistent surgical pain. The Brief Pain Inventory is a reliable and valid measures of the interference of pain with physical functioning and will be used. Additionally patients will be asked about use of pain medications

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo, Intrathecal saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sterile saline, placebo

Morphine

Intrathecal morphine

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

5 mcg/kg intrathecal preservative free morphine sulfate

Interventions

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Morphine Sulfate

5 mcg/kg intrathecal preservative free morphine sulfate

Intervention Type DRUG

Placebo

Sterile saline, placebo

Intervention Type OTHER

Other Intervention Names

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Sterile Saline

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years old
* Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection
* General anesthesia with anticipated intraoperative extubation.

Exclusion Criteria

* American Society of Anesthesiologists (ASA) classification of 4 or 5
* Anticipated postoperative intubation
* Significant liver disease
* Preoperative use of intravenous inotropes and/or vasopressor support
* Preoperative mechanical ventilation
* Preoperative use of mechanical circulatory support device (intraaortic balloon pump, ventricular assist device, extracorporeal membrane oxygenation)
* Severe pulmonary disease (home oxygen requirement and/or current oral steroid use)
* Morphine allergy
* Opioid or alcohol abuse
* Chronic pain
* Renal failure
* Inability to comprehend English language
* Bleeding disorder
* Abnormal preoperative coagulation
* Infection
* Patient refusal
* Failed spinal
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Richa Dhawan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Richa Dhawan, MD MPH

Role: CONTACT

[email protected]
312-695-0061

Facility Contacts

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Ed Fox

Role: primary

[email protected]
773-834-5234

Other Identifiers

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IRB22-0561

Identifier Type: -

Identifier Source: org_study_id