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

ConditionPain, Postoperative
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwestern University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old

Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection

General anesthesia with anticipated intraoperative extubation.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morphine Sulfate

    Drug

    5 mcg/kg intrathecal preservative free morphine sulfate

  • Placebo

    Other intervention

    Sterile saline, placebo

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: MorphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative morphine equivalent consumption

Total MG of analgesic medications given converted to morphine

Time frame
24 hours after surgery

Secondary outcomes

1

Postoperative pain

Visual analog score between 0-10

Time frame
Up to 48 hours postoperative
2

Number of pain interventions

Number of times patient given medication for pain

Time frame
up to 48 hours postoperative
3

Postoperative opioid related side effects

Nausea medication administration, airway events, urinary retention, pruritus medication given,

Time frame
up to 48 hours postoperative
4

Self-reported patient satisfaction

American Pain Society Outcome Questionnaire

Time frame
prior to discharge from hospital, likely 1-3 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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