N/A
N=299
Evaluation of Spine Surgery Analgesic Pathway
Posterior Spine Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02887404 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Quality of Recovery — 109; 109 units on a scale — p=0.92
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spine surgery analgesic pathway (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery |
109; 109 | 0.92 |
| SECONDARY Opioid Utilization |
72; 75 | <0.001 sig |
| SECONDARY Time-weighted Pain Score |
4.8; 5.2 | <0.001 sig |
| SECONDARY Opioid-related Side Effects Score POD1 (Postoperative Day 1) |
2; 2 | — |
| SECONDARY Opioid-related Side Effects Score POD2 (Postoperative Day 2) |
2; 2 | — |
Summary
Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery
Eligibility Criteria
Inclusion Criteria
- 18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients.
- Posterior spine surgery
- Surgery performed at Cleveland Clinic main campus
Exclusion Criteria
- Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin
- Current or recent drug abuse (within past 6 months)
- Pregnancy
- Immune system disease such as HIV, AIDS
- Undergoing immunosuppressive treatment
- Recent history of sepsis
- Contraindications to lidocaine such as heart block and hepatic insufficiency
- Heart failure with ejection fraction less than 30%
- Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher
Data sourced from ClinicalTrials.gov (NCT02887404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.