Post-operative Pain
Conditions
Keywords
Total knee replacement
Brief summary
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
Detailed description
Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.
Interventions
DRUG15mL 0.25% bupivacaine
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
PROCEDUREGenicular nerve block
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
DRUGSaline
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects scheduled for primary elective total knee arthroplasty * American Society of Anesthesiologists Physical Status I-III * BMI 18-40 kg/m2
Exclusion criteria
* Inability to cooperate with protocol * Inability to understand or speak English * Allergy to ropivacaine, bupivacaine or other local anesthetic * Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.) * Revision knee surgery * Chronic opioid consumption (daily morphine equivalent of \>30 mg for at least four weeks prior to surgery) * History of chronic pain * History of psychiatric disorder * History of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption at 24 Hours Post-op | 24 hours after operation | Opioid consumption documented in medical recorded will be converted to oral morphine equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1 | Postoperative Day 1 | The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery. |
| Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1 | Postoperative day 1 | The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery. |
| Total Opioid Consumption Through 48 Hours | 48 hours | Total of all opioids consumed converted to oral morphine equivalents. |
| Opioid Consumption on Postoperative Day 7 | Postoperative day 7 | Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7 |
| Worst Pain Rating Score (NRS-11) on Postoperative Day 7 | Postoperative day 7 | The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery. |
| Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night | Postoperative day 1 | The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight. |
| Patient Satisfaction With Pain Control at 24 h | 24 hours | Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied) |
| Patient Satisfaction With Pain Control on Postoperative Day 7 | Postoperative day 7 | Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied) |
| 20 Meter Walk Test Time Performed on Postoperative Day 1 | On postoperative day 1 | This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.25% bupivacaine 0.67 mg dexamethasone will be administered at each of the 3 genicular nerves. | 20 |
| Genicular Nerve Block With Saline The ultrasound-guided sham genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. 5 mL of 0.9% normal saline will be administered at each of the 3 genicular nerves. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Genicular Nerve Block With Bupivacaine and Dexamethasone | Total | Genicular Nerve Block With Saline |
|---|---|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 6.8 | 68.9 years STANDARD_DEVIATION 7.4 | 67.1 years STANDARD_DEVIATION 7.6 |
| Body Mass Index | 29.3 kg/m∧2 STANDARD_DEVIATION 4.7 | 29.7 kg/m∧2 STANDARD_DEVIATION 4.9 | 30.0 kg/m∧2 STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 40 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 171.1 cm STANDARD_DEVIATION 10 | 170.7 cm STANDARD_DEVIATION 10.5 | 170.4 cm STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 17 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 23 Participants | 13 Participants |
| Weight | 86.5 kg STANDARD_DEVIATION 19.8 | 86.8 kg STANDARD_DEVIATION 18.5 | 87.2 kg STANDARD_DEVIATION 17.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Opioid Consumption at 24 Hours Post-op
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Time frame: 24 hours after operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Opioid Consumption at 24 Hours Post-op | 22.9 milligrams of oral morphine equivalents | Standard Deviation 19.8 |
| Genicular Nerve Block With Saline | Opioid Consumption at 24 Hours Post-op | 58.1 milligrams of oral morphine equivalents | Standard Deviation 34.8 |
Secondary
20 Meter Walk Test Time Performed on Postoperative Day 1
This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time.
Time frame: On postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | 20 Meter Walk Test Time Performed on Postoperative Day 1 | 74.2 seconds | Standard Deviation 40.8 |
| Genicular Nerve Block With Saline | 20 Meter Walk Test Time Performed on Postoperative Day 1 | 80.2 seconds | Standard Deviation 43.6 |
Secondary
Opioid Consumption on Postoperative Day 7
Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Time frame: Postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Opioid Consumption on Postoperative Day 7 | 10.4 milligrams of oral morphine equivalents | Standard Deviation 13.7 |
| Genicular Nerve Block With Saline | Opioid Consumption on Postoperative Day 7 | 22.6 milligrams of oral morphine equivalents | Standard Deviation 24.2 |
Secondary
Patient Satisfaction With Pain Control at 24 h
Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Patient Satisfaction With Pain Control at 24 h | 9.1 score on a scale | Standard Deviation 0.9 |
| Genicular Nerve Block With Saline | Patient Satisfaction With Pain Control at 24 h | 8.6 score on a scale | Standard Deviation 1.1 |
Secondary
Patient Satisfaction With Pain Control on Postoperative Day 7
Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Time frame: Postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Patient Satisfaction With Pain Control on Postoperative Day 7 | 8.8 score on a scale | Standard Deviation 1.6 |
| Genicular Nerve Block With Saline | Patient Satisfaction With Pain Control on Postoperative Day 7 | 8.9 score on a scale | Standard Deviation 1.2 |
Secondary
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.
Time frame: Postoperative day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night | 0 number of times awoken by pain |
| Genicular Nerve Block With Saline | Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night | 1 number of times awoken by pain |
Secondary
Total Opioid Consumption Through 48 Hours
Total of all opioids consumed converted to oral morphine equivalents.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Total Opioid Consumption Through 48 Hours | 50.3 milligrams of oral morphine equivalents | Standard Deviation 39.8 |
| Genicular Nerve Block With Saline | Total Opioid Consumption Through 48 Hours | 97.6 milligrams of oral morphine equivalents | Standard Deviation 56.2 |
Secondary
Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time frame: Postoperative Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1 | 2.7 score on a scale | Standard Deviation 1.9 |
| Genicular Nerve Block With Saline | Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1 | 3.5 score on a scale | Standard Deviation 1.6 |
Secondary
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time frame: Postoperative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Worst Pain Rating Score (NRS-11) on Postoperative Day 7 | 4.4 score on a scale | Standard Deviation 2 |
| Genicular Nerve Block With Saline | Worst Pain Rating Score (NRS-11) on Postoperative Day 7 | 5.0 score on a scale | Standard Deviation 2.2 |
Secondary
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing no pain and 10 unbearable pain. This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Time frame: Postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genicular Nerve Block With Bupivacaine and Dexamethasone | Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1 | 4.9 score on a scale | Standard Deviation 2.4 |
| Genicular Nerve Block With Saline | Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1 | 6.3 score on a scale | Standard Deviation 1.9 |