Rotator Cuff Tears, Shoulder Pain
Conditions
Keywords
peripheral nerve block, interscalene nerve block, bupivacaine, liposomal bupivacaine, ropivacaine, dexamethasone
Brief summary
This study is a comparison of analgesia effect from peripheral nerve blockade (PNB) with liposomal bupivacaine combined with bupivacaine compared to PNB with ropivacaine combined with dexamethasone for arthroscopic rotator cuff repair.
Detailed description
Arthroscopic rotator cuff repair(ARCR) addresses dysfunction and pain in individuals with rotator cuff tears who have failed conservative management. These procedures are typically performed in an outpatient setting. Single shot PNB with long acting local anesthetics have become the foundation of modern multimodal analgesia protocols. The reported analgesic benefits of PNB for shoulder surgery include reduced pain scores, opioid consumption, post-operative nausea and vomiting, improved postoperative recovery and improvement of patient satisfaction. However, standard PNB with bupivacaine or ropivacaine have been associated with rebound pain resulting in a sudden onset of pain that can be refractory to treatment and often necessitates the use of significant quantities of opioids. Side effects of opioid consumption include nausea, vomiting, sedation, constipation, respiratory depression, hypotension, ileus, urinary retention, dehydration and addiction. It is therefore desirable to minimize the requirement for opioid consumption after ARCR. Liposomal bupivacaine injectable suspension and its potential use for PNB has been a recent topic of interest in an effort to provide patients with longer acting pain control after shoulder surgery compared to the use of bupivacaine or ropivacaine. Liposomal bupivacaine has a delayed onset of action so its practical use for PNB for ARCR requires the additive of bupivacaine to reduce pain during and immediately after surgery as a bridge to the onset of liposomal bupivacaine. The purpose of this study is to determine if PNB utilizing liposomal bupivacaine combined with bupivacaine performs favorably to standard PNB with ropivacaine combined with dexamethasone. Primary and secondary outcomes will be assessed including worst pain reported postoperatively on a numeric rating scale(NRS), postoperative opioid consumption reported as oral morphine equivalent dosage(OMED) and the overall benefit of anesthesia (OBAS) as reported by the OBAS score. The hypothesis of this study is that PNB with liposomal bupivacaine combined with bupivacaine will translate to lower postoperative daily NRS pain scores, decreased daily and total OMED consumed and lower OBAS scores compared to PNB with ropivacaine combined with dexamethasone over the first 8 days following surgery.
Interventions
DRUGLiposomal bupivacaine
Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
DRUGRopivacaine 0.5% Injectable Solution
Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
DRUGDexamethasone
Injection of 8mg (2ml) dexamethasone injectable as admixture
Sponsors
Hospital for Special Surgery Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The participant was informed of which arm they were in after random draw as this information may have been important in the event they experienced side effects and needed to guide physician care at outside facilities. The anesthesiologist could not be masked regarding arm as the appearance of the medicine injected in both arms of the study was visibly different. The outcome assessor was masked by unique identifiers being applied to participants and outcome data kept separate from intervention arm until final analysis.
Intervention model description
This study utilized two parallel arms for intervention. Participants were randomized to ultrasound guided PNB with liposomal bupivacaine combined with bupivacaine or PNB with ropivacaine combined with dexamethasone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Full thickness tears of the Supraspinatus tendon * Combined full thickness tears of the Supraspinatus and Infraspinatus tendon
Exclusion criteria
* Age \< 18 * Revision surgery * Chronic opioid use (\>3 months prior to surgery) * Allergy to local anesthetics or opioids * Workers compensation or medical legal claim * Pulmonary disease * NSAID intolerance * Neurologic deficit of operative upper extremity * Concomitant full thickness subscapularis tear * 2 tendon rotator cuff tear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily morphine milligram equivalents of opioid | up to 8 days | Daily opioid consumption reported as OMED |
| Total opioid consumption in morphine milligram equivalents | 8 day period | Total opioid consumption for entire 8 days after surgery |
| Participant reported worst pain level on a numeric rating scale after surgery | up to 8 days | Worst pain level experienced as reported on a numeric rating scale by a participant for each preceding 24 hour period. 0 on numeric rating scale denoting no pain and 10 denoting worst possible pain. |
| Overall benefit of anesthesia score (OBAS) | up to 8 days | Overall benefit of anesthesia score (OBAS) as reported by a participant for each preceding 24 hour period. OBAS is a numeric rating scale. A lower value denotes better pain control and less side effects from anesthesia. Range of scores from 0 to 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain from baseline | up to 8 days | Participant reported change in worst pain level on numeric rating scale from baseline (preoperative) worst pain to worst pain reported on each day after surgery. |
Countries
United States
Outcome results
None listed