Trial Outcomes & Findings for Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery (NCT NCT03693404)

NCT ID: NCT03693404

Last Updated: 2022-07-21

Results Overview

Number of mgs taken of oral morphine

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 190 participants
• Primary outcome timeframe: Post-Operative Day 0
• Results posted on: 2022-07-21

Participant Flow

Participant milestones

Measure	General Anesthesia The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Overall Study STARTED	109	81
Overall Study COMPLETED	108	75
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Measure	General Anesthesia The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	5
Overall Study Excluded from Analysis	0	1

Baseline Characteristics

Effects of a Surgical Site Injection on Pain Scores and Narcotic Use After Orthopaedic Trauma Surgery

Baseline characteristics by cohort

Measure	General Anesthesia n=109 Participants The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia n=75 Participants Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.	Total n=184 Participants Total of all reporting groups
Age, Continuous	75.5 years STANDARD_DEVIATION 15.3 • n=5 Participants	77.5 years STANDARD_DEVIATION 11.6 • n=7 Participants	76.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	47 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	28 Participants n=7 Participants	61 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	62 Participants n=7 Participants	157 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	75 participants n=7 Participants	184 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-Operative Day 0

Number of mgs taken of oral morphine

Outcome measures

Measure	General Anesthesia n=109 Participants The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia n=75 Participants Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Amount (mg) of Narcotics (Oral Morphine mg Equivalents) Used	16 morphine milligram equivalents (MME) Standard Deviation 1.5	10 morphine milligram equivalents (MME) Standard Deviation 1.4

PRIMARY outcome

Timeframe: Post-operative Day 3

Ambulation is the ability to walk without the need for any kind of assistance. It is most often used when describing the goals of a patient after a surgery or physical therapy.

Outcome measures

Measure	General Anesthesia n=109 Participants The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia n=75 Participants Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Ambulation Distance	48.7 Feet Standard Deviation 8	88.9 Feet Standard Deviation 17.6

PRIMARY outcome

Timeframe: Hour 24

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Outcome measures

Measure	General Anesthesia n=109 Participants The control group will receive no injection into area surrounding the fracture site General Anesthetics: Placebo group will only receive standard of care general anesthesia	Spinal Anesthesia n=75 Participants Injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Marcaine, Duramorph , ketorolac: Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision. Bupivacaine (Marcaine): 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
Score on Visual Analogue Scale (VAS) for Pain	3.3 score on a scale Standard Deviation 1.7	2.5 score on a scale Standard Deviation 1.4

Adverse Events

General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philipp Leucht, MD

NYU Langone Health

Phone: 646-501-0291

Email: philipp.leucht@nyulangone.org

Results disclosure agreements

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