Pain, PostoperativePhase 4NCT05351229
Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery
A Phase 4 study testing Morphine Sulfate in people with Pain, Postoperative, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
- Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection
- General anesthesia with anticipated intraoperative extubation.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Ed Fox, 773-834-5234, efox1@bsd.uchicago.edu
About this study
Official title: Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
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.
Read the 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
- Conditions
- Pain, Postoperative
- Being tested
- Morphine Sulfate, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
5 mcg/kg intrathecal preservative free morphine sulfate
PlaceboOther
Also called Sterile Saline
Sterile saline, placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, Intrathecal saline Receives: Other: Placebo |
| Morphine | Active comparator | Intrathecal morphine Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine equivalent consumption
Total MG of analgesic medications given converted to morphine
Measured: 24 hours after surgery
Secondary outcomes (7)
Postoperative pain
Visual analog score between 0-10
Measured: Up to 48 hours postoperative
Number of pain interventions
Number of times patient given medication for pain
Measured: up to 48 hours postoperative
Postoperative opioid related side effects
Nausea medication administration, airway events, urinary retention, pruritus medication given,
Measured: up to 48 hours postoperative
Self-reported patient satisfaction
American Pain Society Outcome Questionnaire
Measured: prior to discharge from hospital, likely 1-3 days after surgery
pain qualities
pain intensity, location, quality via Brief Pain Inventory
Measured: 1 month and 3 months after surgery
Self reported use of analgesic medications
Questions asked via phone call at 1 month and 3 months.
Measured: 1 month and 3 months after surgery
self-reported limitation of daily activity at 1 and 3 months
Questions asked via phone call at 1 month and 3 months
Measured: 1 month and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start29 Sep 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richa Dhawan, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351229
- Sponsor's protocol ID
- IRB22-0561
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary to conduct study or data analysis
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05351229
- Acronym / sponsor ID
- IRB22-0561
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo, Intrathecal saline |
| Morphine | Active comparator | Drug: Morphine SulfateIntrathecal morphine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years old
- Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection
- General anesthesia with anticipated intraoperative extubation.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine Sulfate5 mcg/kg intrathecal preservative free morphine sulfate | Drug | Morphine |
| PlaceboAlso: Sterile SalineSterile saline, placebo | Other | Placebo |
Primary outcome
Postoperative morphine equivalent consumption
Time frame: 24 hours after surgery
Total MG of analgesic medications given converted to morphine
7 secondary outcomes
Postoperative pain
Time frame: Up to 48 hours postoperative
Number of pain interventions
Time frame: up to 48 hours postoperative
Postoperative opioid related side effects
Time frame: up to 48 hours postoperative
Self-reported patient satisfaction
Time frame: prior to discharge from hospital, likely 1-3 days after surgery
pain qualities
Time frame: 1 month and 3 months after surgery
Self reported use of analgesic medications
Time frame: 1 month and 3 months after surgery
self-reported limitation of daily activity at 1 and 3 months
Time frame: 1 month and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No. Not necessary to conduct study or data analysis
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine Sulfate in people with Pain, Postoperative, run by Northwestern University 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 3 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richa Dhawan, MD MPH (312-695-0061, richa.dhawan@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine equivalent consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.