Adverse Effects, Postoperative Pain
Conditions
Keywords
Single injection interscalene brachial plexus block, Continuous interscalene brachial plexus block, General anesthesia, Postoperative pain, Recovery profile
Brief summary
The investigators undertook this prospective, randomized trial to compare the recovery profile throughout the first postoperative week in patients receiving continuous (CISB) interscalene brachial plexus block, single injection (SISB), or general anesthesia (GA) for arthroscopic rotator cuff repair surgery. Specifically, the effects of the three anesthetic techniques when used intraoperatively as a sole anesthesia modality were studied on postoperative pain, time-to-first pain, analgesic consumption, fast-tracked PACU bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects. The investigators hypothesized that CISB results in a superior postoperative recovery profile as compared to SISB or GA alone.
Detailed description
Background The advantages of single injection (SISB) and continuous interscalene brachial plexus block (CISB) over general anesthesia (GA) only have been previously reported. However, few studies extended their observations beyond 48 postoperative hours, and no study has compared the effects of SISB and CISB as sole anesthesia modalities with GA only. We undertook this randomized trial to compare the recovery profile of patients receiving SISB, CISB or GA for arthroscopic rotator cuff repair surgery through the first postoperative week. Our primary hypothesis was that highest NRS pain rating (worst pain score) at the end of the study week is lower for patients in the CISB group than for patients in the SISB or GA groups. Methods After Institutional Review Board approval and informed consents were obtained, 71 patients of American Society of Anesthesiologists (ASA) physical status I-III, ≥18 years of age, and BMI≤35 kg/m2, scheduled for elective outpatient arthroscopic rotator cuff repair, were enrolled. CISB patients received 20 mL of 0.5% ropivacaine as bolus through the catheter whereas SISB patients received the same volume of injection through a needle. CISB patients received an infusion of 0.2% ropivacaine at 5mL/h with a patient controlled bolus of 5 mL hourly. GA only patients received a standardized general anesthetic. All patients were prescribed acetaminophen (500mg) with hydrocodone (7.5mg) every 4h as needed. CISB was discontinued 48 h after surgery. Postoperative highest pain scores (NRS) through the first postoperative week, time-to-first pain, analgesic consumption, fast-tracked postoperative care unit (PACU) bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects were recorded in the PACU and at home on postoperative days 1, 2, 3, and 7.
Interventions
PROCEDUREISB
In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.
Sponsors
Baxter Healthcare Corporation
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
American Society of Anesthesiologists (ASA) physical status I-III patients ≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery
Exclusion criteria
Patients who were undertaken open shoulder procedures Patients with difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales Patients with contraindications to regional anesthesia (e.g., allergy to a local anesthetic (LA), local infection, coagulopathy) Patients with significant neurologic disorders of the upper extremity, psychiatric or cognitive disorders, history of substance abuse or chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 | throughout the first postoperative week on days 1, 2, 3, and 7 | The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-first Pain | throughout the first postoperative week | The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain). |
| The Number of Patients Consume ≥1 Dose of Analgesics | throughout the first postoperative week | The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number | throughout the first postoperative week (how many patients left PACU immediately just after the operation) | To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate |
| Total Hours of Sleep | first postoperative week (on day 7) | To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration. |
| Length of PACU Stay | throughout the first postoperative week (how long patients stayed in PACU just after the operation) | To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay. |
| Time to Discharge Home | throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time) | To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home. |
Countries
United States
Participant flow
Recruitment details
St Luke's-Roosevelt Hospital Center between August 2011 and June 2012
Pre-assignment details
One patient enrolled preferred to get SISB instead of GA and was therefore not randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Single ISB (SISB) Group Patients in this group received single injection (SISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter. | 24 |
| Continuous ISB (CISB) Group Patients in this group received continuous (CISB) interscalene brachial plexus block
ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter. | 24 |
| General Anesthesia (GA) Group Patients in this group received general anesthesia (GA) | 22 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Continuous ISB (CISB) Group | General Anesthesia (GA) Group | Single ISB (SISB) Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 19 Participants | 58 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 9 | 55 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 24 participants | 22 participants | 24 participants | 70 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 11 Participants | 26 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 / 23 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 5 / 23 | 0 / 20 | 2 / 20 |
Outcome results
Primary
Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4
The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)
Time frame: throughout the first postoperative week on days 1, 2, 3, and 7
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single ISB (SISB) Group | Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 | 19 participants |
| Continuous ISB (CISB) Group | Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 | 5 participants |
| General Anesthesia (GA) Group | Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4 | 11 participants |
Secondary
The Number of Patients Consume ≥1 Dose of Analgesics
The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).
Time frame: throughout the first postoperative week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single ISB (SISB) Group | The Number of Patients Consume ≥1 Dose of Analgesics | 16 participants |
| Continuous ISB (CISB) Group | The Number of Patients Consume ≥1 Dose of Analgesics | 12 participants |
| General Anesthesia (GA) Group | The Number of Patients Consume ≥1 Dose of Analgesics | 13 participants |
Secondary
Time-to-first Pain
The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).
Time frame: throughout the first postoperative week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single ISB (SISB) Group | Time-to-first Pain | 11 hours | Standard Deviation 5 |
| Continuous ISB (CISB) Group | Time-to-first Pain | 26 hours | Standard Deviation 24 |
| General Anesthesia (GA) Group | Time-to-first Pain | 2 hours | Standard Deviation 3 |
Other Pre-specified
Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number
To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate
Time frame: throughout the first postoperative week (how many patients left PACU immediately just after the operation)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single ISB (SISB) Group | Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number | 20 participants |
| Continuous ISB (CISB) Group | Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number | 19 participants |
| General Anesthesia (GA) Group | Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number | 0 participants |
Other Pre-specified
Length of PACU Stay
To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.
Time frame: throughout the first postoperative week (how long patients stayed in PACU just after the operation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single ISB (SISB) Group | Length of PACU Stay | 30 minutes | Standard Deviation 42 |
| Continuous ISB (CISB) Group | Length of PACU Stay | 20 minutes | Standard Deviation 31 |
| General Anesthesia (GA) Group | Length of PACU Stay | 165 minutes | Standard Deviation 118 |
Other Pre-specified
Time to Discharge Home
To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.
Time frame: throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single ISB (SISB) Group | Time to Discharge Home | 115 minutes | Standard Deviation 109 |
| Continuous ISB (CISB) Group | Time to Discharge Home | 94 minutes | Standard Deviation 55 |
| General Anesthesia (GA) Group | Time to Discharge Home | 302 minutes | Standard Deviation 249 |
Other Pre-specified
Total Hours of Sleep
To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.
Time frame: first postoperative week (on day 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single ISB (SISB) Group | Total Hours of Sleep | 5 hours | Standard Deviation 2 |
| Continuous ISB (CISB) Group | Total Hours of Sleep | 7 hours | Standard Deviation 1 |
| General Anesthesia (GA) Group | Total Hours of Sleep | 6 hours | Standard Deviation 2 |