Postoperative Pain
Conditions
Brief summary
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.
Interventions
PROCEDURELumbar Plexus Blockade
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
PROCEDUREControl
The control group will receive only a combined spinal-epidural.
Sponsors
New York Presbyterian Hospital
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) Class 1-3 * Patients aged 18 to 65 years * Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat * Planned use of neuraxial anesthesia * Body Mass Index less than 35 * Ability to follow study protocol
Exclusion criteria
* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months) * Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities. * Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities. * Infection at the injection site(s) * Allergy to any of the study medications * Contraindication to a short course of NSAIDs (renal failure, intolerance) * ASA Class 4-5 * Patient refusal * Patients younger than 18 years old and older than 65 * Patients with any known indwelling hardware of the lumbar spine. * Patients with a peripheral neuropathy of the surgical extremity * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Pain Medication Needed | Day of surgery prior to discharge | — |
| Incidence of Nausea | Day of surgery prior to discharge | The number of participants with nausea. |
| Incidence of Vomiting | Day of surgery prior to discharge | The number of participants who vomited. |
| Readiness to Discharge From Post-Anesthesia Care Unit (PACU) | Day of surgery prior to discharge | 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. |
| Patient Satisfaction | First 24 hours after surgery | Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied) |
| Quality of Recovery (QoR-40) Physical Comfort Dimension | First 24 hours after surgery | Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome |
| Requirement of Antiemetic Rescue | Day of surgery prior to discharge | The number of participants who needed medication to treat their nausea and vomiting. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Control Group The control group received only a combined spinal-epidural. | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | Lumbar Plexus Blockade + CSE | Control Group | Total |
|---|---|---|---|
| Age Continuous | 33 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 41 |
| serious Total, serious adverse events | 3 / 42 | 2 / 41 |
Outcome results
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.
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge | 3.3 units on a scale | Standard Deviation 2.2 |
| Control Group | Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge | 4.2 units on a scale | Standard Deviation 1.8 |
Secondary
Incidence of Nausea
The number of participants with nausea.
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Plexus Blockade + CSE | Incidence of Nausea | 14 participants |
| Control Group | Incidence of Nausea | 8 participants |
Secondary
Incidence of Vomiting
The number of participants who vomited.
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Plexus Blockade + CSE | Incidence of Vomiting | 1 participants |
| Control Group | Incidence of Vomiting | 3 participants |
Secondary
Narcotic Pain Medication Needed
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Narcotic Pain Medication Needed | 21 equivalents milligrams oral morphine | Standard Deviation 17 |
| Control Group | Narcotic Pain Medication Needed | 29 equivalents milligrams oral morphine | Standard Deviation 21 |
Secondary
Patient Satisfaction
Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
Time frame: First 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Patient Satisfaction | 8.6 units on a scale | Standard Deviation 1.6 |
| Control Group | Patient Satisfaction | 7.9 units on a scale | Standard Deviation 2.5 |
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
Time frame: First 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Quality of Recovery (QoR-40) Physical Comfort Dimension | 53 QoR-40 Physical Comfort score | Standard Deviation 4.3 |
| Control Group | Quality of Recovery (QoR-40) Physical Comfort Dimension | 52 QoR-40 Physical Comfort score | Standard Deviation 7.4 |
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.
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Plexus Blockade + CSE | Readiness to Discharge From Post-Anesthesia Care Unit (PACU) | 216 minutes | Standard Deviation 86 |
| Control Group | Readiness to Discharge From Post-Anesthesia Care Unit (PACU) | 187 minutes | Standard Deviation 59 |
Secondary
Requirement of Antiemetic Rescue
The number of participants who needed medication to treat their nausea and vomiting.
Time frame: Day of surgery prior to discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Plexus Blockade + CSE | Requirement of Antiemetic Rescue | 5 participants |
| Control Group | Requirement of Antiemetic Rescue | 5 participants |