Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Average Postoperative Pain Score
Study Overview
Brief Summary
Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic pain > 6 months
- •Long term use of opioids
- •Major surgery
Exclusion Criteria
- •Use of regional anesthetic techniques
- •No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
Arms & Interventions
Ketamine
Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
Intervention: Ketamine (Drug)
Ketamine
Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.
Intervention: Hydromorphone PCA (Drug)
Placebo
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Intervention: Placebo (Drug)
Placebo
Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).
Intervention: Hydromorphone PCA (Drug)
Outcomes
Primary Outcomes
Average Postoperative Pain Score
Time Frame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.
Secondary Outcomes
- 24-Hour Postoperative Opioid Use(For 24 hours following surgery)
- Worst Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
- Least Postoperative Pain Score(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
- Number of Participants With Treatment Related Adverse Events (AEs)(Participants were followed for the duration of hospital stay, an average of approximately 3 days.)
Investigators
Srdjan Nedeljkovic
Staff, Pain Management Center
Brigham and Women's Hospital