Trial Outcomes & Findings for Management of Postoperative Pain After Total Knee Replacement. (NCT NCT01163214)

NCT ID: NCT01163214

Last Updated: 2014-11-05

Results Overview

Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 160 participants
• Primary outcome timeframe: Afternoon on post-operative Day 1, approximately 14:00
• Results posted on: 2014-11-05

Participant Flow

Subjects were recruited from Mayo Clinic, Phoenix, Arizona from September 2010 to February 2013.

Participant milestones

Measure	Nerve Block Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Overall Study STARTED	79	81
Overall Study COMPLETED	79	81
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Postoperative Pain After Total Knee Replacement.

Baseline characteristics by cohort

Measure	Nerve Block n=79 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.	Total n=160 Participants Total of all reporting groups
Age, Continuous	67.8 years STANDARD_DEVIATION 7.9 • n=5 Participants	67.7 years STANDARD_DEVIATION 7.2 • n=7 Participants	67.7 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	48 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	79 participants n=5 Participants	81 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: Afternoon on post-operative Day 1, approximately 14:00

Population: Intention to treat analysis

Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).

Outcome measures

Measure	Nerve Block n=79 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Post-Operative Pain	2.9 units on a scale Standard Deviation 2.4	3.0 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Afternoon on post-operative Day 1, approximately 14:00

Population: In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.)

Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).

Outcome measures

Measure	Nerve Block n=74 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=77 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	2.9 units on a scale Standard Deviation 2.4	3.1 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2

Population: Intention to treat analysis

Use of additional narcotic medications (as needed), measured in morphine equivalents.

Outcome measures

Measure	Nerve Block n=79 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Narcotic Use Intraoperative	17.4 mg Standard Deviation 10.1	23.6 mg Standard Deviation 8.5
Narcotic Use Day of Surgery	4.6 mg Standard Deviation 9.1	11.7 mg Standard Deviation 13.1
Narcotic Use Post-Operative Day 1	43.0 mg Standard Deviation 29.0	49.0 mg Standard Deviation 29.0
Narcotic Use Post-Operative Day 2	33.0 mg Standard Deviation 28.0	30.0 mg Standard Deviation 29.0

SECONDARY outcome

Timeframe: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon

Population: The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label.

Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.

Outcome measures

Measure	Nerve Block n=78 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=80 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Straight-leg Raise Day 1 AM (Nerve Block=78, Injection=80)	19 participants	63 participants
Straight-leg Raise Day 1 PM (Nerve Block=76, Injection=78)	21 participants	63 participants
Straight-leg Raise Day 2 AM (Nerve Block=78, Injection=79)	52 participants	69 participants
Straight-leg Raise Day 2 PM (Nerve Block=69, Injection=51)	57 participants	42 participants

SECONDARY outcome

Timeframe: Approximately 2 days after surgery

Population: The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.

Length of stay data were calculated from the medical record.

Outcome measures

Measure	Nerve Block n=74 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Length of Stay in Hospital	2.84 days Standard Deviation 1.34	2.44 days Standard Deviation 0.65

SECONDARY outcome

Timeframe: 6 weeks postoperative

Population: The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants.

Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.

Outcome measures

Measure	Nerve Block n=78 Participants Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=79 Participants Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Number of Subjects Who Experienced Neurological Changes Postoperatively Femoral nerve (nerve block n=77)	1 participants	0 participants
Number of Subjects Who Experienced Neurological Changes Postoperatively Common peroneal nerve (nerve block n=78)	6 participants	0 participants
Number of Subjects Who Experienced Neurological Changes Postoperatively Tibial nerve (nerve block n=78)	2 participants	1 participants
Number of Subjects Who Experienced Neurological Changes Postoperatively Femoral, peroneal, or tibial (nerve block n=77)	9 participants	1 participants

Adverse Events

Nerve Block

Serious events: 4 serious events

Other events: 55 other events

Deaths: 0 deaths

Periarticular Injection

Serious events: 0 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nerve Block n=79 participants at risk Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 participants at risk Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Blood and lymphatic system disorders Acute Pulmonary Embolism	1.3% 1/79 • Number of events 1 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.
Renal and urinary disorders Acute Renal Failure	1.3% 1/79 • Number of events 1 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.
Musculoskeletal and connective tissue disorders Lumbar Vertebral Fracture After Fall	1.3% 1/79 • Number of events 1 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.
Blood and lymphatic system disorders Stroke Middle Cerebral Artery	1.3% 1/79 • Number of events 1 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.

Other adverse events

Measure	Nerve Block n=79 participants at risk Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.	Periarticular Injection n=81 participants at risk Injection combination prior to skin closure. Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Gastrointestinal disorders Vomiting	24.1% 19/79 • Number of events 19 • Adverse events were collected from within 4 days of the surgery.	19.8% 16/81 • Number of events 16 • Adverse events were collected from within 4 days of the surgery.
Injury, poisoning and procedural complications Fall	3.8% 3/79 • Number of events 3 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.
Ear and labyrinth disorders Syncope	3.8% 3/79 • Number of events 3 • Adverse events were collected from within 4 days of the surgery.	1.2% 1/81 • Number of events 1 • Adverse events were collected from within 4 days of the surgery.
Renal and urinary disorders Urinary Tract Infection	2.5% 2/79 • Number of events 2 • Adverse events were collected from within 4 days of the surgery.	0.00% 0/81 • Adverse events were collected from within 4 days of the surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.5% 2/79 • Number of events 2 • Adverse events were collected from within 4 days of the surgery.	2.5% 2/81 • Number of events 2 • Adverse events were collected from within 4 days of the surgery.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/79 • Adverse events were collected from within 4 days of the surgery.	2.5% 2/81 • Number of events 2 • Adverse events were collected from within 4 days of the surgery.
Renal and urinary disorders Urinary Retention	32.9% 26/79 • Number of events 26 • Adverse events were collected from within 4 days of the surgery.	40.7% 33/81 • Number of events 33 • Adverse events were collected from within 4 days of the surgery.

Additional Information

Mark J. Spangehl, M.D.

Mayo Clinic

Phone: 480-342-2377

Email: spangehl.mark@mayo.edu

Results disclosure agreements

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