Trial Outcomes & Findings for Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery (NCT NCT04156581)

NCT ID: NCT04156581

Last Updated: 2024-12-27

Results Overview

The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: 0-24 hours after surgery (intraoperative + immediately after surgery)
• Results posted on: 2024-12-27

Participant Flow

All recruitment conducted at the Hospital for Special Surgery between 11/2019 and 6/2022.

Participant milestones

Measure	ESPB With Bupivacaine and Dexamethasone 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

Baseline characteristics by cohort

Measure	ESPB With Bupivacaine and Dexamethasone n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.	Total n=46 Participants Total of all reporting groups
Age, Continuous	59.13 years STANDARD_DEVIATION 18.02 • n=5 Participants	57.26 years STANDARD_DEVIATION 16.48 • n=7 Participants	58.2 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Body Mass Index	25.36 kg/m^2 STANDARD_DEVIATION 4.35 • n=5 Participants	24.49 kg/m^2 STANDARD_DEVIATION 3.55 • n=7 Participants	24.93 kg/m^2 STANDARD_DEVIATION 3.95 • n=5 Participants
Weight	70.46 kg STANDARD_DEVIATION 16.31 • n=5 Participants	66.23 kg STANDARD_DEVIATION 12.88 • n=7 Participants	68.35 kg STANDARD_DEVIATION 14.69 • n=5 Participants
Height	1.66 meters STANDARD_DEVIATION .014 • n=5 Participants	1.64 meters STANDARD_DEVIATION 0.1 • n=7 Participants	1.65 meters STANDARD_DEVIATION 0.12 • n=5 Participants

PRIMARY outcome

Timeframe: 0-24 hours after surgery (intraoperative + immediately after surgery)

The total amount of opioid taken during surgery and 24 hours after surgery, measured in morphine milligram equivalent (MME).

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Intraoperative and Postoperative Opioid Consumption	191 MME/day Standard Deviation 195.2	139.4 MME/day Standard Deviation 70.5

SECONDARY outcome

Timeframe: at baseline (holding area), post anesthesia care unit (PACU) (hour 0), hour 6, 12, and 24 hours after surgery

Measured by Numeric Rating Scale (NRS) pain at rest (The minimum value 0 being 'no pain' and the maximum value 10 being 'as bad as you can imagine').

Higher scores means a worse outcome.

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Numeric Rating Scale Pain at Rest Pain Scores at Rest at baseline	2.74 score on a scale Standard Deviation 2.56	3.04 score on a scale Standard Deviation 2.2
Numeric Rating Scale Pain at Rest Pain Scores at Rest at PACU (0 hours)	3.56 score on a scale Standard Deviation 3.93	4.15 score on a scale Standard Deviation 4.07
Numeric Rating Scale Pain at Rest Pain Scores at Rest at 6 hours	3.33 score on a scale Standard Deviation 2.35	3.9 score on a scale Standard Deviation 2.49
Numeric Rating Scale Pain at Rest Pain Scores at Rest at 12 hours	3.19 score on a scale Standard Deviation 2.1	3.87 score on a scale Standard Deviation 2.53
Numeric Rating Scale Pain at Rest Pain Scores at Rest at 24 hours	3.86 score on a scale Standard Deviation 2.1	4.05 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: on post-operative physical therapy day 0, 1, and 2

Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.

Measured by Numeric Rating Scale (NRS) pain with movement (The minimum value 0 being 'no pain' and the maximum value 10 being 'as bad as you can imagine').

Higher scores means a worse outcome.

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=21 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=20 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Pain Scores With Physical Therapy Pain with movement (physical therapy) at POD 2	4.94 score on a scale Standard Deviation 2.95	3.53 score on a scale Standard Deviation 2.85
Pain Scores With Physical Therapy Pain with movement (physical therapy) at POD 0	3 score on a scale Standard Deviation 1.41	2 score on a scale Standard Deviation 2.45
Pain Scores With Physical Therapy Pain with movement (physical therapy) at POD 1	4.29 score on a scale Standard Deviation 2.8	3.9 score on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: at baseline (holding area), 24 and 72 hours after surgery

Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.

Quality of recovery (QoR) after anesthesia measures the early postoperative health status of patients. QoR15 is the shortened (15 questions) version, each question is scored on the following scales: (Part A: 0 to 10 where 0=none of the time [poor] and 10=all the time [excellent]; Part B: 0 to 10 where 10=none of the time [poor] and 0=all the time [excellent]).

The total recovery score is scored on the following scale excellent= 136-150, good=122-135, moderate=90-121, and poor=0-89.

A lower score means a worst outcome.

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=22 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=20 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Quality of Recovery Quality of recovery (QoR) at preop	101.36 score on a scale Standard Deviation 10.62	99.45 score on a scale Standard Deviation 10.53
Quality of Recovery Quality of recovery (QoR) at 24 hours	69.85 score on a scale Standard Deviation 14.75	74.73 score on a scale Standard Deviation 10.22
Quality of Recovery Quality of recovery (QoR) at 72 hours	79.67 score on a scale Standard Deviation 11.89	79.82 score on a scale Standard Deviation 12.53

SECONDARY outcome

Timeframe: at 24 hours after surgery

Population: The Number of Participants Analyzed differs from the number of participants assigned to each arm due to lost to follow up.

The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale (minimum = 0 to maximum = 4) that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness). Measured by 10 symptoms on the following scale: did not have symptom = 0, slight = 1, moderate = 2, severe = 3, very severe = 4.

The total score for each participant was calculated and then the average score for the group was reported.

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=18 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=14 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Opioid Related Side Effects	2.56 score on a scale Standard Deviation 0.67	2.24 score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: at 72 hours after surgery

Measured by bang blinding index (choose between two treatment arms and provide explanation as to why arm was chosen). The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.

The blinding assessment was completed by the participant, research assistant and anesthesiologist (principle investigator).

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=22 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=22 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Blinding Assessment Bang Blinding Index (participants' response)	.045 score on a scale Interval -0.24 to 0.33	-0.048 score on a scale Interval -0.33 to 0.23
Blinding Assessment Bang Blinding Index (research assistant's response)	0.318 score on a scale Interval 0.01 to 0.62	-0.045 score on a scale Interval -0.37 to 0.28
Blinding Assessment Bang Blinding Index (anesthesiologist's response)	0.381 score on a scale Interval 0.08 to 0.64	-0.429 score on a scale Interval -0.73 to -0.12

SECONDARY outcome

Timeframe: up to 24 hours after surgery

Time to pressing opioid use via intravenous administration (IV PCA)

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=22 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=22 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Time to First Opioid Use Via Intravenous Administration	237.73 minutes Standard Deviation 185.91	286.23 minutes Standard Deviation 458.77

SECONDARY outcome

Timeframe: up to 24 hours after surgery

Time to pressing opioid use via oral administration (Oral PCA)

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=21 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Time to Opioid Consumption Via Oral Administration	254.62 minutes Standard Deviation 360.87	141.09 minutes Standard Deviation 271.87

SECONDARY outcome

Timeframe: 0-12 hours after surgery (intraoperative + immediately after surgery)

Measured in morphine milligram equivalent (MME).

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
Total Opioid Consumption	21.83 MME/day Standard Deviation 15.42	25.48 MME/day Standard Deviation 18.37

SECONDARY outcome

Timeframe: 24 hours after surgery

The total opioid consumption at 24 hours post-operatively, measured in morphine milligrams equivalent (MME).

Outcome measures

Measure	ESPB With Bupivacaine and Dexamethasone n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 Participants 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
24 Hours Post-operative Opioid Consumption	42.9 MME/day Standard Deviation 31.1	47.6 MME/day Standard Deviation 33.2

Adverse Events

ESPB With Bupivacaine and Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ESPB With Saline Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ESPB With Bupivacaine and Dexamethasone n=23 participants at risk 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.375% bupivacaine plus 2 mg preservative free dexamethasone, 25-30 mL total per side according to patient weight. Bupivacaine: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone: Dexamethasone is a corticosteroid that reduces inflammation.	ESPB With Saline Placebo n=23 participants at risk 23 complex spine surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with saline placebo, 25-30 mL total per side according to patient weight. Saline: Saline is a mixture of NaCl and water that can be used as a placebo.
General disorders Post-operative tachycardia and hypoxia	0.00% 0/23 • Adverse events data will be collected over the course of study enrollment and research activities. For this study, adverse events for each participant were assessed from the day of enrollment to the last day of study follow up, post-operative day 3.	4.3% 1/23 • Number of events 1 • Adverse events data will be collected over the course of study enrollment and research activities. For this study, adverse events for each participant were assessed from the day of enrollment to the last day of study follow up, post-operative day 3.

Additional Information

Dr. Justas Lauzadis

Hospital for Special Surgery

Phone: 212-774-2946

Email: lauzadisj@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place