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Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks

Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks Versus Placebo for Pain Control After Arthroscopic Rotator Cuff Repair

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02462382
Enrollment
51
Registered
2015-06-04
Start date
2013-09-01
Completion date
2016-05-20
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-thickness Rotator Cuff Tear

Brief summary

Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very painful when the block wears off. The purpose of this study is to: 1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair. 2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair. 3. Evaluate for any continued pain relief benefit of continuous infusion scalene block ropivacaine catheters during the three days after the infusion catheters have finished.

Detailed description

Patients undergoing arthroscopic rotator cuff repair by one of the three attending surgeon authors at Orlando Orthopaedic Outpatient Surgery Center will be candidates for the study. Further inclusion criteria will be a full-thickness rotator cuff tear, age eighteen or greater, a reparable rotator cuff tear and willingness to consent to study participation. Patients will not be excluded for concomitant procedures such as acromioplasty, distal clavicle resection, biceps tenotomy and biceps tenodesis. Exclusion criteria will include age less than eighteen, irreparable rotator cuff tear, subscapularis tear requiring repair, labral tear requiring repair, allergy to ropivacaine or a similar local anesthetic agent and allergy to oxycodone. All patients will undergo an ultrasound guided ISB with 30cc of 0.5% ropivacaine with epinephrine in the preoperative holding area by an anesthesiologist trained in regional block anesthesia. A continuous infusion catheter will be placed under ultrasound guidance to confirm appropriate position. An adhesive dressing on the skin will be used to keep the catheter in position and away from the operating field. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline. Randomization will be performed by block number randomization and the group assignments will be placed in sealed envelopes. The envelopes will be opened by the operating room circulating nurse. Both patients and surgeons will be blinded to the randomization. Patients and their families will be educated preoperative and postoperative on the removal of the pain catheters. There will be written instructions regarding catheter removal. Patients or their family members will remove the catheters after the reservoirs are empty. The study authors will be available to assist with any catheter removal issues that the patients may have. Patients will be prescribed oxycodone 5mg tablets for their postoperative pain control. Patients will receive diaries to record their pain levels utilizing visual analog scores (VAS) for the first five postoperative days. The first pain level will be recorded in the post anesthesia care unit. Pain levels will then be recorded twice daily. Patients will also be asked to log their oxycodone use during the first five postoperative days. Patients will be educated preoperative on the postoperative diaries. They will also receive a call from an OOOSC nurse on postoperative day one to address any questions or concerns. Patients will be evaluated in the office by the operating surgeon at one week postoperative. At that time, study diaries will be collected.

Interventions

PROCEDUREArthroscopic Rotator Cuff Repair

During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.

DRUGRopivacaine

The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.

DRUGSaline

The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.

Sponsors

Orlando Health, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.

Exclusion criteria

1. Prior surgery on the involved shoulder 2. Preoperative MRI suggesting that the rotator cuff tear is irreparable 3. Patients with known allergies to oxycodone, ropivacaine or a similar drug 4. Workman's compensation patients 5. Patients who do not fill out their visual analog scores or their medication diaries 6. Patients with labral or subscapularis tears requiring repair

Design outcomes

Primary

MeasureTime frameDescription
Mean Visual Analog ScaleDuring the first two Post Operative Days.Shoulder Pain as measured by Visual Analog Scale, score 0-10. 0 equals no pain, 10 equals severe pain. Data not available for each tear size, all attempts were made to locate.

Secondary

MeasureTime frameDescription
Mean Visual Analog Scale ScorePost Operative Days (POD) 3, 4 and 5.Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain.
Oxycodone ConsumptionPost operative days 1 and 2.
Oxycodone Consumption After the First Two Postoperative Days.Post Operative Days 3, 4 and 5.

Countries

United States

Participant flow

Recruitment details

Potential subjects were asked to participate during their clinic visits.

Participants by arm

ArmCount
Ropivacaine Infusion
270cc of Ropivacaine infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline. Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament. Ropivacaine
24
Saline Infusion
270cc of Normal Saline infusion at 5cc per hour. All patients will receive a reservoir for their catheters containing 280cc of either ropivacaine or saline that will infuse at a rate of 6cc per hour. The reservoirs will be attached in the operating room at the completion of the rotator cuff repair. Patients will be randomized intraoperative to receive either the ropivacaine or the saline. Arthroscopic Rotator Cuff Repair: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament. Saline
27
Total51

Baseline characteristics

CharacteristicRopivacaine InfusionSaline InfusionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
23 Participants26 Participants49 Participants
Mean Visual Analog Scale Score
POD 0 1cm incision
0.3 Units on a scale0 Units on a scale0.3 Units on a scale
Mean Visual Analog Scale Score
POD 0 2cm incision
0.9 Units on a scale0.8 Units on a scale0.85 Units on a scale
Mean Visual Analog Scale Score
POD 0 3cm incision
0.23 Units on a scale0.24 Units on a scale0.23 Units on a scale
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
9 Participants9 Participants18 Participants
Sex: Female, Male
Male
15 Participants18 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 27
other
Total, other adverse events
0 / 240 / 27
serious
Total, serious adverse events
0 / 240 / 27

Outcome results

Primary

Mean Visual Analog Scale

Shoulder Pain as measured by Visual Analog Scale, score 0-10. 0 equals no pain, 10 equals severe pain. Data not available for each tear size, all attempts were made to locate.

Time frame: During the first two Post Operative Days.

Population: The study did not compare patients based on tear/incision size. All attempts were made to locate this data but it is unavailable.

ArmMeasureGroupValue (MEAN)
Ropivacaine InfusionMean Visual Analog ScalePOD 1 3cm incision4.0 units on a scale
Ropivacaine InfusionMean Visual Analog ScalePOD1 1cm incision3.5 units on a scale
Ropivacaine InfusionMean Visual Analog ScalePOD 2 2cm incision3.1 units on a scale
Ropivacaine InfusionMean Visual Analog ScalePOD 1 2cm incision3.1 units on a scale
Ropivacaine InfusionMean Visual Analog ScalePOD 2 3 cm incision3.8 units on a scale
Ropivacaine InfusionMean Visual Analog ScalePOD 2 1cm incision2.9 units on a scale
Saline InfusionMean Visual Analog ScalePOD 2 3 cm incision4.1 units on a scale
Saline InfusionMean Visual Analog ScalePOD 1 2cm incision5.2 units on a scale
Saline InfusionMean Visual Analog ScalePOD 1 3cm incision5.4 units on a scale
Saline InfusionMean Visual Analog ScalePOD 2 1cm incision4.0 units on a scale
Saline InfusionMean Visual Analog ScalePOD 2 2cm incision3.6 units on a scale
Saline InfusionMean Visual Analog ScalePOD1 1cm incision5.9 units on a scale
Comparison: Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).p-value: 0.006Chi-squared
Secondary

Mean Visual Analog Scale Score

Visual Analog Scale pain scale score 0-10. 0 equals no pain, 10 equals severe pain.

Time frame: Post Operative Days (POD) 3, 4 and 5.

Population: All attempts were made to locate the data for the number of participants with different incision/tear sizes, but the data are not available.

ArmMeasureGroupValue (MEAN)
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 3 2cm incision3.3 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 4 3cm incision2.8 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 4 1 cm incision2.6 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 5 1cm incision2.3 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 3 3cm incision3.2 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 5 2cm incision2.2 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 4 2cm incision2.6 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 5 3cm incision2.8 units on a scale
Ropivacaine InfusionMean Visual Analog Scale ScorePOD 3 1cm incision3.5 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 5 3cm incision3.0 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 3 1cm incision3.3 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 3 2cm incision3.1 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 3 3cm incision3.4 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 4 1 cm incision3.5 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 4 2cm incision3.2 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 4 3cm incision3.3 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 5 1cm incision3.0 units on a scale
Saline InfusionMean Visual Analog Scale ScorePOD 5 2cm incision2.6 units on a scale
Secondary

Oxycodone Consumption

Time frame: Post operative days 1 and 2.

ArmMeasureGroupValue (MEAN)
Ropivacaine InfusionOxycodone ConsumptionPOD 25.8 Pills
Ropivacaine InfusionOxycodone ConsumptionPOD 15.8 Pills
Saline InfusionOxycodone ConsumptionPOD 18.3 Pills
Saline InfusionOxycodone ConsumptionPOD 27.9 Pills
Secondary

Oxycodone Consumption After the First Two Postoperative Days.

Time frame: Post Operative Days 3, 4 and 5.

ArmMeasureGroupValue (MEAN)
Ropivacaine InfusionOxycodone Consumption After the First Two Postoperative Days.POD 35.5 Pills
Ropivacaine InfusionOxycodone Consumption After the First Two Postoperative Days.POD 43.9 Pills
Ropivacaine InfusionOxycodone Consumption After the First Two Postoperative Days.POD 53.6 Pills
Saline InfusionOxycodone Consumption After the First Two Postoperative Days.POD 35.8 Pills
Saline InfusionOxycodone Consumption After the First Two Postoperative Days.POD 44.7 Pills
Saline InfusionOxycodone Consumption After the First Two Postoperative Days.POD 53.7 Pills

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026