Post-operative Pain
Conditions
Keywords
Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis
Brief summary
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.
Detailed description
Aims: 1. To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses. 2. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses. 3. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses. 4. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses. 5. To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses. 6. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
Interventions
DRUGRopivacaine
Initial Bolus 5 ml Ropivacaine via interscalene injection
Sponsors
Beaumont Foundation of America
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to participation in the study. * Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff. * If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care * Be at least 18, but not more than 80 years of age * Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA). * Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff. * Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable.
Exclusion criteria
* Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study. * Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties). * Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation. * Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications. * Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years. * Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination. * Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurements Via Numeric Pain Rating Scales (NRS) | Discharge, 24 h, 48h, 12 weeks | Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable) |
| Change in Diaphragmatic Displacement From Baseline to Post-surgery | Baseline, Post anesthesia care unit (PACU) - within 8 hours | Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | at 24 and 48 hours after discharge from the hospital | Participants were asked to rate the helpfulness of their infusion: 1. extremely harmful 2. harmful 3. neutral 4. not harmful, but not helpful 5. helpful 6. extremely helpful |
| Functional Outcome - Simple Shoulder Test (SST) | Baseline, 12 weeks | At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed. |
Countries
United States
Participant flow
Recruitment details
Patients were identified from the surgical schedule. Subjects consented using the most current IRB-approved consent form. Informed consent were administered in the pre-operative suites prior to receiving any treatment. Recruitment started after approval was obtained from the IRB. Recruitment period was Jan 2009 to Dec 2009.
Pre-assignment details
Subjects were screened per protocol, those that met all inclusion criteria and did not meet any exclusion criteria were randomized per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine 5 mL Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. | 12 |
| Ropivacaine 10 mL Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. | 12 |
| Ropivacaine 20 mL Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out. | 12 |
| Total | 36 |
Baseline characteristics
| Characteristic | Ropivacaine 10 mL | Total | Ropivacaine 20 mL | Ropivacaine 5 mL |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 36 Participants | 12 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 36 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 11 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 25 Participants | 9 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change in Diaphragmatic Displacement From Baseline to Post-surgery
Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.
Time frame: Baseline, Post anesthesia care unit (PACU) - within 8 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine 5 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement ipsilateral | 66 percent change |
| Ropivacaine 5 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement contralateral | -28 percent change |
| Ropivacaine 10 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement ipsilateral | 60 percent change |
| Ropivacaine 10 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement contralateral | -56 percent change |
| Ropivacaine 20 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement ipsilateral | 65 percent change |
| Ropivacaine 20 mL | Change in Diaphragmatic Displacement From Baseline to Post-surgery | % change in diaphragm displacement contralateral | -39 percent change |
Primary
Pain Measurements Via Numeric Pain Rating Scales (NRS)
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Time frame: Discharge, 24 h, 48h, 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine 5 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at Discharge | 2.67 units on a scale |
| Ropivacaine 5 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 24 hours post discharge | 3.67 units on a scale |
| Ropivacaine 5 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 48 hours post discharge | 2.67 units on a scale |
| Ropivacaine 5 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 12 weeks post discharge (n=11, 12, 12) | 1.5 units on a scale |
| Ropivacaine 10 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 12 weeks post discharge (n=11, 12, 12) | 2.42 units on a scale |
| Ropivacaine 10 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at Discharge | 1.58 units on a scale |
| Ropivacaine 10 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 48 hours post discharge | 2.08 units on a scale |
| Ropivacaine 10 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 24 hours post discharge | 3.33 units on a scale |
| Ropivacaine 20 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 12 weeks post discharge (n=11, 12, 12) | 1.15 units on a scale |
| Ropivacaine 20 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 24 hours post discharge | 2.54 units on a scale |
| Ropivacaine 20 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at 48 hours post discharge | 2.15 units on a scale |
| Ropivacaine 20 mL | Pain Measurements Via Numeric Pain Rating Scales (NRS) | NRS at Discharge | 0.62 units on a scale |
Secondary
Functional Outcome - Simple Shoulder Test (SST)
At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.
Time frame: Baseline, 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine 5 mL | Functional Outcome - Simple Shoulder Test (SST) | SST at Baseline (n=36) | 6.3 units on a scale |
| Ropivacaine 5 mL | Functional Outcome - Simple Shoulder Test (SST) | SST at 12 weeks (n=35) | 8.2 units on a scale |
Secondary
Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful
Participants were asked to rate the helpfulness of their infusion: 1. extremely harmful 2. harmful 3. neutral 4. not harmful, but not helpful 5. helpful 6. extremely helpful
Time frame: at 24 and 48 hours after discharge from the hospital
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropivacaine 5 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 24 hours | 83 percentage of participants |
| Ropivacaine 5 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 48 hours | 83 percentage of participants |
| Ropivacaine 10 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 24 hours | 83 percentage of participants |
| Ropivacaine 10 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 48 hours | 75 percentage of participants |
| Ropivacaine 20 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 24 hours | 92 percentage of participants |
| Ropivacaine 20 mL | Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Percentage of participants at 48 hours | 85 percentage of participants |