Lumbar Disc Herniation Clinical Trial
Official title:
Evaluating General Anesthesia With Erector Spinae Plane Block vs. Spinal Anesthesia With Erector Spinae Plane Block in Lumbar Decompression Surgeries
Verified date | October 2023 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.
Status | Enrolling by invitation |
Enrollment | 142 |
Est. completion date | September 27, 2024 |
Est. primary completion date | September 27, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients from the ages 18- 80 years - Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels. - Able to follow study protocol - Able to provide informed consent Exclusion Criteria: - Surgery with planned need for postoperative surgical drain. - Allergies of contraindication to any study anesthetic or analgesic medications. - Morbid obesity, defined as BMI > 35 kg/m2. - Involved in the study of another investigational product that may affect the outcome. |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QoR15 survey scores | The primary outcome is the difference in the quality of recovery-15 (QoR15) score between the groups at each timepoint (before surgery, after surgery, and at their first 2 week follow-up visit). For this survey, a high number represents something that occurs often, while a low number indicates something that rarely or never occurs. Depending on the category/question asked, this may be good or bad. The questions on the survey will be split and compared so that for one subset of questions a high number is good while the opposite is true for the other subset of questions. This will be done so the comparison between groups is more accurate and meaningful. | The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits | |
Secondary | NRS Survey Pain Scores | Numeric rating scale (NRS) survey will be asked in holding (before surgery), in the PACU (after surgery), and at the patients first 2week follow-up visit. Most patients will be discharged a few hours after waking up, barring no complications, therefore may only be assessed the NRS survey immediately after surgery (same as QoR15). For this scale (0-10), a higher number indicates more pain in that specified body part, while a lower score indicates little or no pain in that body part. | The NRS will be assessed preoperatively (in holding area), postoperatively in PACU, and 2 weeks postoperatively at the patient's first follow-up | |
Secondary | Opioid Consumption | Opioid consumption will be tracked intraoperatively and total from PACU arrival to 24 hours surgery | From surgery through 24 hours postoperatively | |
Secondary | Anesthetic(s) Time | induction (from induction to anesthesia-ready), emergence (from surgery-end to out-of-OR for SA group; and from surgery-end to extubation for GA groups); duration of SA (from placement to resolution). | Intraoperatively | |
Secondary | Surgical Duration | Time of surgery will be compared between groups from skin incision to skin closure | Intraoperatively | |
Secondary | Complications | nausea, vomiting, urinary retention, escalation to a higher level of postoperative care, conversion from SA to GA, neurologic (extremity numbness, weakness, paresthesia). | Length of stay at the hospital (up to 3 days postoperatively) |
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