Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| New York Presbyterian Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Experimental | The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. |
|
| Control Group | Placebo Comparator | The control group will receive only a combined spinal-epidural. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Plexus Blockade | Procedure | The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge | The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable. | Day of surgery prior to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness to Discharge From Post-Anesthesia Care Unit (PACU) | Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacques T YaDeau, M.D., Ph.D. | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States | ||
| New York Presbyterian Hospital |
Not provided
| Label | URL |
|---|---|
| This is the link for the Hospital for Special Surgery website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lumbar Plexus Blockade + CSE | The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. |
| FG001 | Control Group | The control group received only a combined spinal-epidural. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lumbar Plexus Blockade + CSE | The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge | The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable. | Posted | Mean | Standard Deviation | units on a scale | Day of surgery prior to discharge |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumbar Plexus Blockade + CSE | The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admission for nausea | Gastrointestinal disorders | Systematic Assessment | 1 control patient was admitted to the hospital for intractable nausea (attributed to opioid analgesics) |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques YaDeau | Hospital for Special Surgery | 212-606-1206 | yadeauj@hss.edu |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Procedure | The control group will receive only a combined spinal-epidural. |
|
| Day of surgery prior to discharge |
| Narcotic Pain Medication Needed | Day of surgery prior to discharge |
| Incidence of Nausea | The number of participants with nausea. | Day of surgery prior to discharge |
| Incidence of Vomiting | The number of participants who vomited. | Day of surgery prior to discharge |
| Requirement of Antiemetic Rescue | The number of participants who needed medication to treat their nausea and vomiting. | Day of surgery prior to discharge |
| Patient Satisfaction | Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied) | First 24 hours after surgery |
| Quality of Recovery (QoR-40) Physical Comfort Dimension | Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome | First 24 hours after surgery |
| New York |
| New York |
| 10065 |
| United States |
The control group received only a combined spinal-epidural.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Readiness to Discharge From Post-Anesthesia Care Unit (PACU) | Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated. | Posted | Mean | Standard Deviation | minutes | Day of surgery prior to discharge |
|
|
|
| Secondary | Narcotic Pain Medication Needed | Posted | Mean | Standard Deviation | equivalents milligrams oral morphine | Day of surgery prior to discharge |
|
|
|
| Secondary | Incidence of Nausea | The number of participants with nausea. | Posted | Number | participants | Day of surgery prior to discharge |
|
|
|
| Secondary | Incidence of Vomiting | The number of participants who vomited. | Posted | Number | participants | Day of surgery prior to discharge |
|
|
|
| Secondary | Requirement of Antiemetic Rescue | The number of participants who needed medication to treat their nausea and vomiting. | Posted | Number | participants | Day of surgery prior to discharge |
|
|
|
| Secondary | Patient Satisfaction | Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied) | Posted | Mean | Standard Deviation | units on a scale | First 24 hours after surgery |
|
|
|
| Secondary | Quality of Recovery (QoR-40) Physical Comfort Dimension | Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome | Posted | Mean | Standard Deviation | QoR-40 Physical Comfort score | First 24 hours after surgery |
|
|
|
| 3 |
| 42 |
| 0 |
| 42 |
| EG001 | Control Group | The control group received only a combined spinal-epidural. | 2 | 41 | 0 | 41 |
|
| Admission for oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 1 control patient was admitted to the hospital for hypoxemia (attributed to opioid analgesics) |
|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 2 LPB patients fell in the hospital bathroom without injury |
|
| Admission for epidural spread | Injury, poisoning and procedural complications | Systematic Assessment | 1 LPB patient was admitted for epidural spread and urinary retention (procedural complication) |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |