Trial Outcomes & Findings for Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management (NCT NCT04567407)

Results Overview

Total opiate equivalents

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

24hours postop

Results posted on

2023-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bilateral Erector Spinae Blocks All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Overall Study STARTED	45
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Erector Spinae Blocks n=45 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Age, Categorical <=18 years	45 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants
Age, Continuous	11.15 years n=45 Participants
Sex: Female, Male Female	23 Participants n=45 Participants
Sex: Female, Male Male	22 Participants n=45 Participants
Region of Enrollment United States	45 participants n=45 Participants

PRIMARY outcome

Timeframe: 24hours postop

Total opiate equivalents

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Analgesic Requirement	0.60 (mg/kg) Standard Error 0.06

PRIMARY outcome

Timeframe: 48hours postop

Total opiate equivalents

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Analgesic Requirement	1.13 mg/kg Standard Error 0.08

PRIMARY outcome

Timeframe: 96hours postop

Total opiate equivalents

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Analgesic Requirement	1.34 (mg/kg) Interval 0.87 to 2.0

SECONDARY outcome

Timeframe: 48hrs

Length of postoperative mechanical ventilation/intubation following OR exit

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Duration of Mechanical Ventilation/Intubation	0.7 hours Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 72Hours

Duration of ICU stay following OR exit

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Length of Postoperative ICU Stay	23.3 hours Interval 22.1 to 50.1

SECONDARY outcome

Timeframe: 5 Days

Duration of Inpatient hospital admission

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Length of Hospital Stay	4.10 days Interval 3.83 to 5.08

SECONDARY outcome

Timeframe: day of surgery (POD 0) 7:00am - 18:59pm

Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Median Pain Scores	3.30 score on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: night of surgery (PON 0) 19:00pm-6:59am

Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Median Pain Scores	3.46 score on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Post-Op Day 1 (7:00am-18:59pm)

Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Median Pain Scores	3.18 score on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: Post-Op Night 1 (19:00pm-6:59am)

Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Median Pain Scores	2.92 score on a scale Standard Error 0.33

SECONDARY outcome

Timeframe: 48 hours

Time to out of bed activity (e.g., up to chair, ambulation)

Outcome measures

Outcome measures
Measure	Bilateral Erector Spinae Blocks n=40 Participants All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Time to First Mobilization	6.75 hours Interval 5.03 to 9.83

Adverse Events

Bilateral Erector Spinae Blocks

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bilateral Erector Spinae Blocks n=40 participants at risk All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols). Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.
Skin and subcutaneous tissue disorders Catheter obstruction - unilateral	5.0% 2/40 • Number of events 2 • 30 days All patients were rounded on by study team members daily while in hospital. Per routine standard of care, they saw a Physician Assistant on POD 7 with a standardized questionnaire, they received patient reported outcomes surveys at 5, 10 and 20 days and they had a virtual 30-day questionnaire. In addition, all additional postoperative visits were reviewed, including Emergency Department admissions, as applicable.
Skin and subcutaneous tissue disorders Catheter leakage under dressing	12.5% 5/40 • Number of events 5 • 30 days All patients were rounded on by study team members daily while in hospital. Per routine standard of care, they saw a Physician Assistant on POD 7 with a standardized questionnaire, they received patient reported outcomes surveys at 5, 10 and 20 days and they had a virtual 30-day questionnaire. In addition, all additional postoperative visits were reviewed, including Emergency Department admissions, as applicable.
Skin and subcutaneous tissue disorders Bleeding/hematoma	5.0% 2/40 • Number of events 2 • 30 days All patients were rounded on by study team members daily while in hospital. Per routine standard of care, they saw a Physician Assistant on POD 7 with a standardized questionnaire, they received patient reported outcomes surveys at 5, 10 and 20 days and they had a virtual 30-day questionnaire. In addition, all additional postoperative visits were reviewed, including Emergency Department admissions, as applicable.
Nervous system disorders Chest wall paresthesia	2.5% 1/40 • Number of events 1 • 30 days All patients were rounded on by study team members daily while in hospital. Per routine standard of care, they saw a Physician Assistant on POD 7 with a standardized questionnaire, they received patient reported outcomes surveys at 5, 10 and 20 days and they had a virtual 30-day questionnaire. In addition, all additional postoperative visits were reviewed, including Emergency Department admissions, as applicable.

Additional Information

Roland Brusseau MD

Boston Children's Hospital

Phone: 857-218-4814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place