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Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Morphine Sulfate
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years old
  • Undergoing elective video-assisted thoracoscopic 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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Morphine

Arm Description

Intrathecal saline

Intrathecal morphine

Outcomes

Primary Outcome Measures

Postoperative morphine equivalent consumption
Total MG of analgesic medications given converted to morphine

Secondary Outcome Measures

Postoperative pain
Visual analog score between 0-10
Number of pain interventions
Number of times patient given medication for pain
Postoperative opioid related side effects
Nausea medication administration, airway events, urinary retention, pruritus medication given,
Self-reported patient satisfaction
American Pain Society Outcome Questionnaire
pain qualities
pain intensity, location, quality via Brief Pain Inventory
Self reported use of analgesic medications
Questions asked via phone call at 1 month and 3 months.
self-reported limitation of daily activity at 1 and 3 months
Questions asked via phone call at 1 month and 3 months

Full Information

First Posted
April 13, 2022
Last Updated
January 19, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05351229
Brief Title
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
Official Title
Intrathecal Morphine for Postoperative Analgesia in Video-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intrathecal saline
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Intervention Description
5 mcg/kg intrathecal preservative free morphine sulfate
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile Saline
Intervention Description
Sterile saline
Primary Outcome Measure Information:
Title
Postoperative morphine equivalent consumption
Description
Total MG of analgesic medications given converted to morphine
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Visual analog score between 0-10
Time Frame
Up to 48 hours postoperative
Title
Number of pain interventions
Description
Number of times patient given medication for pain
Time Frame
up to 48 hours postoperative
Title
Postoperative opioid related side effects
Description
Nausea medication administration, airway events, urinary retention, pruritus medication given,
Time Frame
up to 48 hours postoperative
Title
Self-reported patient satisfaction
Description
American Pain Society Outcome Questionnaire
Time Frame
prior to discharge from hospital, likely 1-3 days after surgery
Title
pain qualities
Description
pain intensity, location, quality via Brief Pain Inventory
Time Frame
1 month and 3 months after surgery
Title
Self reported use of analgesic medications
Description
Questions asked via phone call at 1 month and 3 months.
Time Frame
1 month and 3 months after surgery
Title
self-reported limitation of daily activity at 1 and 3 months
Description
Questions asked via phone call at 1 month and 3 months
Time Frame
1 month and 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years old Undergoing elective video-assisted thoracoscopic 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richa Dhawan, MD MPH
Phone
773-702-1000
Email
rdhawan@dacc.uchicago.edu
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ed Fox
Phone
773-834-5234
Email
efox1@bsd.uchicago.edu

12. IPD Sharing Statement

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Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery

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