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Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone

Duration of Interscalene Nerve Blocks With Ropivacaine Alone, Ropivacaine Mixed With Dexamethasone, and Ropivacaine Alone Combined With Systemic Dexamethasone

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519584
Acronym
Ropivacaine
Enrollment
218
Registered
2007-08-22
Start date
2007-07-31
Completion date
2009-03-31
Last updated
2017-07-21

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

Conditions

Pain

Keywords

Interscalene nerve block, Dexamethasone, Ropivacaine

Brief summary

This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.

Detailed description

This study proposes to recruit 120 patients who are undergoing open shoulder surgery. Patients will be identified preoperatively by means of the surgical schedule at each participating location. Randomization will be generated by a web-based system and stratified by hospital. The attending physician will be blinded to the contents of the supplied syringes. Treatment assignments consist of three groups: * Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block; * Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; * bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block. * bupivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; All solutions for interscalene block will contain epinephrine 1:400,000 as a marker for intravascular injection. Insulated needles with nerve stimulation will be used. Motor response in the surgical limb at a current of \< 0.4 mA at 0.1 msec duration will be considered evidence of adequate needle position. Patients will be evaluated at 5-minute intervals for 15 minutes for development of sensory and motor block. Sensory block will be assessed by loss of sensation to pinprick over the deltoid muscle. Motor block will be assessed by evaluation of ability to abduct the shoulder, the so-called deltoid sign. During surgery, patients will receive either general anesthesia or sedation at the discretion of the attending anesthesiologist. Demographic variables, morphometric measurements, and the specific type of procedure will be recorded. The intraoperative management strategy (i.e. general anesthesia versus sedation) and the total doses of fentanyl, midazolam, morphine, and propofol administered perioperatively will be recorded. Finger-stick blood glucose will be measured upon arrival in the postanesthesia care unit (PACU). The primary outcome will be the duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication. The severity of postoperative pain will be assessed by a blinded observer using a verbal response score (VRS) at 10-minute intervals for 30 minutes in the PACU. Patients reporting pain scores greater than 2 will be given intravenous morphine (1-2 mg) every 5 minutes until they are comfortable. After discharge from the PACU pain unrelieved by oral medication (VRS persistently greater than 4) will be treated with intravenous morphine. Outpatients will receive a prescription for oral acetaminophen with oxycodone. A blinded observer will interview patients each morning for three days postoperatively. Data collected will include time of block duration,the primary outcome; defined as time from onset of sensory blockade to first administration of supplemental analgesic medication after PACU discharge, as well as secondary outcomes: time to a significant increase in shoulder discomfort, time to a noticeable decrease in numbness and/or weakness, maximum VRS with rest and movement, and total opioid consumption. The times and VRS scores for secondary outcomes will be based on patient reporting of the corresponding events daily. A member of the study staff will contact patients at 14 days postoperatively to assess for any late or persistent complications such as residual sensory or motor block.

Interventions

DRUGRopivacaine

30 ml 0.5%

DRUGdex

8 mg (2 ml)

DRUGBupivacaine

30 ml 0.5%

DRUGSaline

0.9% saline; systemic and local

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing open shoulder procedures such as rotator cuff repair, capsular shift, subacromial decompression * Age between 18 and 70 years

Exclusion criteria

* Contradictions for interscalene block * Coagulopathy * Infection at the needle insertion site * Moderate to severe chronic obstructive pulmonary disease (COPD) * Contralateral pneumothorax of diaphragmatic paralysis * Pregnancy * Preexisting neuropathy involving the surgical limb * Systemic glucocorticoid treatment within the last six months of surgery * Routine opioid use

Design outcomes

Primary

MeasureTime frameDescription
the Duration of Analgesiasurgical date to postoperative day 1 (pod 0 -1 day)the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain

Secondary

MeasureTime frameDescription
Time to a Significant Increase in Shoulder Discomfortduring postoperative day 1 to 3the length of time until the patients' first report of surgical site pain.
Maximum VRS Pain Scores at Restpostoperative day 1 day 2, day 3.Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.
Total Opioid Consumptionduring first 3 days after surgerycumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.

Countries

United States

Participant flow

Participants by arm

ArmCount
Ropivacaine/Saline
Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block Ropivacaine: 30 ml 0.5% Saline: 0.9% saline; systemic and local
54
Ropivacaine/Dex
Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block; Ropivacaine: 30 ml 0.5% dex: 8 mg (2 ml)
54
Bupivacaine/Dex
bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block. dex: 8 mg (2 ml) Bupivacaine: 30 ml 0.5%
54
Bupivacaine/Saline
bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block Bupivacaine: 30 ml 0.5% Saline: 0.9% saline; systemic and local
56
Total218

Baseline characteristics

CharacteristicRopivacaine/SalineRopivacaine/DexBupivacaine/DexBupivacaine/SalineTotal
Age, Continuous55 years59 years58 years60 years59 years
Sex: Female, Male
Female
21 Participants21 Participants21 Participants19 Participants82 Participants
Sex: Female, Male
Male
33 Participants33 Participants33 Participants37 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 540 / 540 / 540 / 56
serious
Total, serious adverse events
0 / 540 / 540 / 540 / 56

Outcome results

Primary

the Duration of Analgesia

the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain

Time frame: surgical date to postoperative day 1 (pod 0 -1 day)

ArmMeasureValue (MEDIAN)
Ropivacaine/Salinethe Duration of Analgesia22.2 hours
Ropivacaine/Dexthe Duration of Analgesia11.8 hours
Bupivacaine/Dexthe Duration of Analgesia14.8 hours
Bupivacaine/Salinethe Duration of Analgesia22.4 hours
p-value: <0.00195% CI: [0.08, 0.39]Log Rank
p-value: <0.00195% CI: [0.23, 0.83]Log Rank
Secondary

Maximum VRS Pain Scores at Rest

Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.

Time frame: postoperative day 1 day 2, day 3.

ArmMeasureGroupValue (MEDIAN)
Ropivacaine/SalineMaximum VRS Pain Scores at RestPOD#15 units on a scale
Ropivacaine/SalineMaximum VRS Pain Scores at RestPOD#31.9 units on a scale
Ropivacaine/SalineMaximum VRS Pain Scores at RestPOD#23 units on a scale
Ropivacaine/DexMaximum VRS Pain Scores at RestPOD#13.9 units on a scale
Ropivacaine/DexMaximum VRS Pain Scores at RestPOD#32.9 units on a scale
Ropivacaine/DexMaximum VRS Pain Scores at RestPOD#23 units on a scale
Bupivacaine/DexMaximum VRS Pain Scores at RestPOD#24.1 units on a scale
Bupivacaine/DexMaximum VRS Pain Scores at RestPOD#13 units on a scale
Bupivacaine/DexMaximum VRS Pain Scores at RestPOD#34 units on a scale
Bupivacaine/SalineMaximum VRS Pain Scores at RestPOD#14.9 units on a scale
Bupivacaine/SalineMaximum VRS Pain Scores at RestPOD#31.8 units on a scale
Bupivacaine/SalineMaximum VRS Pain Scores at RestPOD#24.1 units on a scale
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary

Time to a Significant Increase in Shoulder Discomfort

the length of time until the patients' first report of surgical site pain.

Time frame: during postoperative day 1 to 3

ArmMeasureValue (MEDIAN)
Ropivacaine/SalineTime to a Significant Increase in Shoulder Discomfort22.3 hours
Ropivacaine/DexTime to a Significant Increase in Shoulder Discomfort11.9 hours
Bupivacaine/DexTime to a Significant Increase in Shoulder Discomfort14.7 hours
Bupivacaine/SalineTime to a Significant Increase in Shoulder Discomfort25.7 hours
p-value: <0.001Log Rank
p-value: <0.001Log Rank
Secondary

Total Opioid Consumption

cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.

Time frame: during first 3 days after surgery

ArmMeasureValue (MEDIAN)
Ropivacaine/SalineTotal Opioid Consumption75 mg
Ropivacaine/DexTotal Opioid Consumption79 mg
Bupivacaine/DexTotal Opioid Consumption60 mg
Bupivacaine/SalineTotal Opioid Consumption85 mg
p-value: 0.29Wilcoxon (Mann-Whitney)
p-value: 0.15Wilcoxon (Mann-Whitney)

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