Trial · NCT01163214

Management of Postoperative Pain After Total Knee Replacement.

NCT01163214, Phase 4, Completed, Mark J. Spangehl, M.D.; results first posted 2014-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Management of Postoperative Pain After Total Knee Replacement. Trials, record NCT01163214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01163214

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Management of Postoperative Pain After Total Knee Replacement.
NCT number: NCT01163214
Status: Completed
Phases: Phase 4
Enrollment: 160 participants, actual
Lead sponsor: Mark J. Spangehl, M.D.
Conditions: Postoperative Pain, Knee Replacement Arthroplasty
Interventions: Nerve Block, Periarticular Injection
First posted: 2010-07-15
Last updated: 2014-11-05
Results first posted: 2014-11-05
Limitations and caveats: Participants and staff could not be blinded to the treatment arm received; participants' pain was evaluated at rest and not with activity; the study was not powered to identify certain rare events such as falls.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Post-Operative Pain	Afternoon on post-operative Day 1, approximately 14:00	Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Secondary	Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	Afternoon on post-operative Day 1, approximately 14:00	Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Secondary	Narcotic Use	Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2	Use of additional narcotic medications (as needed), measured in morphine equivalents.
Secondary	Straight-leg Raise	Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon	Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
Secondary	Length of Stay in Hospital	Approximately 2 days after surgery	Length of stay data were calculated from the medical record.
Secondary	Number of Subjects Who Experienced Neurological Changes Postoperatively	6 weeks postoperative	Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	Afternoon on post-operative Day 1, approximately 14:00	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.)	units on a scale	MEAN
PRIMARY	Post-Operative Pain	Afternoon on post-operative Day 1, approximately 14:00	Intention to treat analysis	units on a scale	MEAN
SECONDARY	Narcotic Use	Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2	Intention to treat analysis	mg	MEAN
SECONDARY	Straight-leg Raise	Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon	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.	participants	NUMBER
SECONDARY	Length of Stay in Hospital	Approximately 2 days after surgery	The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.	days	MEAN
SECONDARY	Number of Subjects Who Experienced Neurological Changes Postoperatively	6 weeks postoperative	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	NUMBER

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	Nerve Block		2.9	Standard Deviation 2.4	units on a scale
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	Periarticular Injection		3.1	Standard Deviation 2.2	units on a scale
Post-Operative Pain	Nerve Block		2.9	Standard Deviation 2.4	units on a scale
Post-Operative Pain	Periarticular Injection		3.0	Standard Deviation 2.2	units on a scale
Narcotic Use	Nerve Block	Intraoperative	17.4	Standard Deviation 10.1	mg
Narcotic Use	Periarticular Injection	Intraoperative	23.6	Standard Deviation 8.5	mg
Narcotic Use	Nerve Block	Day of Surgery	4.6	Standard Deviation 9.1	mg
Narcotic Use	Periarticular Injection	Day of Surgery	11.7	Standard Deviation 13.1	mg
Narcotic Use	Nerve Block	Post-Operative Day 1	43.0	Standard Deviation 29.0	mg
Narcotic Use	Periarticular Injection	Post-Operative Day 1	49.0	Standard Deviation 29.0	mg

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nerve Block	79
Overall Study	STARTED	Periarticular Injection	81
Overall Study	COMPLETED	Nerve Block	79
Overall Study	COMPLETED	Periarticular Injection	81
Overall Study	NOT COMPLETED	Nerve Block	0
Overall Study	NOT COMPLETED	Periarticular Injection	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Vomiting	Gastrointestinal disorders	Nerve Block	19	79	19
other	Vomiting	Gastrointestinal disorders	Periarticular Injection	16	81	16
other	Fall	Injury, poisoning and procedural complications	Nerve Block	3	79	3
other	Fall	Injury, poisoning and procedural complications	Periarticular Injection	0	81	0
other	Syncope	Ear and labyrinth disorders	Nerve Block	3	79	3
other	Syncope	Ear and labyrinth disorders	Periarticular Injection	1	81	1
other	Urinary Tract Infection	Renal and urinary disorders	Nerve Block	2	79	2
other	Urinary Tract Infection	Renal and urinary disorders	Periarticular Injection	0	81	0
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Nerve Block	2	79	2
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Periarticular Injection	2	81	2

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nerve Block
Total, all-cause mortality	Periarticular Injection
Total, other adverse events	Nerve Block	55	79
Total, other adverse events	Periarticular Injection	54	81
Total, serious adverse events	Nerve Block	4	79
Total, serious adverse events	Periarticular Injection	0	81

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24706022	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UL1TR000135	Mayo Clinic Center for Clinical and Translational Science (CCaTS)	KHOSLA, SUNDEEP	MAYO CLINIC ROCHESTER	NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES	2012 to 2015

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Nerve Block vs Periarticular Injection: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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