Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT01586806
• Collaborator: (none)
• Enrollment: 195
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.

Depending on the randomized treatment assignment, patients may receive one of the following:

1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);

2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;

3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.

Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, Saphenous Nerve Block	Drug: Bupivacaine Only; Drug: Bupivacaine with 1 mg of Dexamethasone; Drug: Bupivacaine with 4 mg of Dexamethasone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control	Drug: Bupivacaine Only; This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
Active Comparator: Dexamethasone 1 mg	Drug: Bupivacaine with 1 mg of Dexamethasone; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
Active Comparator: Dexamethasone 4 mg	Drug: Bupivacaine with 4 mg of Dexamethasone; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Outcome Measures

Primary Outcome Measures

1. Patient-perceived Duration of Analgesia [Up to 2 days following surgery]

   After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.

Secondary Outcome Measures

1. NRS (Numerical Rating Scale) Pain Scores [Postoperative day 1]

   Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.

2. Patient Satisfaction [Up to 2 days following surgery]

   Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);

3. Postoperative Morphine Consumption [Up to 2 days following surgery]

   Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.

4. Opioid-Related Side Effects (Drowsiness) [Up to 2 days following surgery]

   Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.

• ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]

• BMI < 35

• Smokers included

• Ages 16-65

Exclusion Criteria:

• Patients on steroids or requiring stress dose steroids

• BMI > 35

• Patient refusal

• Allergy to study medications,

• NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks

• Lower extremity neurological dysfunction

• Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)

• Not in included age range (under 16 or over 65 years of age)

• Contraindications to the use of dexamethasone

• Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Mary F. Chisholm, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• This is the link to Hospital for Special Surgery website.

Publications

• Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gümüş H, Ateş Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
• Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38.
• Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
• Lundblad M, Kapral S, Marhofer P, Lönnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. Epub 2006 Sep 26.
• Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36.
• Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01586806
• Other Study ID Numbers: IRB #2012-002
• First Posted: Apr 27, 2012
• Last Update Posted: Nov 28, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Hospital for Special Surgery, New York: Dexamethasone; Glucocorticoids; Physiological Effects of Drugs; Therapeutic Uses; Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, nerve block; Ultrasonic Imaging; Post-Operative Complications: muscle weakness, pain, nausea and vomiting; Dexamethasone (as local anesthetic additive)
• Additional relevant MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101

Study Results

Participant Flow

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Period Title: Overall Study
STARTED	65	65	65
COMPLETED	62	61	63
NOT COMPLETED	3	4	2

Baseline Characteristics

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg	Total
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.	Total of all reporting groups
Overall Participants	62	61	63	186
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (10)	26 (8)	27 (10)	26 (9)
Sex: Female, Male (Count of Participants)
Female	19 30.6%	27 44.3%	19 30.2%	65 34.9%
Male	43 69.4%	34 55.7%	44 69.8%	121 65.1%
Region of Enrollment (participants) [Number]
United States	62 100%	61 100%	63 100%	186 100%
Body Mass Index (kg/(m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/(m^2)]	24 (3)	24 (4)	25 (3)	25 (4)

Outcome Measures

1. Primary Outcome

Title	Patient-perceived Duration of Analgesia
Description	After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
Time Frame	Up to 2 days following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Measure Participants	62	61	63
Median (95% Confidence Interval) [hours]	33	41	46.5

2. Secondary Outcome

Title	NRS (Numerical Rating Scale) Pain Scores
Description	Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.
Time Frame	Postoperative day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Measure Participants	62	61	63
Median (Inter-Quartile Range) [units on a scale]	3	3	2

3. Secondary Outcome

Title	Patient Satisfaction
Description	Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
Time Frame	Up to 2 days following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Measure Participants	62	61	63
Median (Inter-Quartile Range) [units on a scale]	8	8	9

4. Secondary Outcome

Title	Postoperative Morphine Consumption
Description	Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.
Time Frame	Up to 2 days following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Measure Participants	62	61	63
Median (Inter-Quartile Range) [milligrams]	45	30	30

5. Secondary Outcome

Title	Opioid-Related Side Effects (Drowsiness)
Description	Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.
Time Frame	Up to 2 days following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Dexamethasone 1 mg	Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).	Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.	Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Measure Participants	62	61	63
Median (Inter-Quartile Range) [units on a scale]	1.1	1	0

Adverse Events

Arm/Group Title	Control		Dexamethasone 1 mg		Dexamethasone 4 mg
Arm/Group Description	Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).		Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.		Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
All Cause Mortality
	Control		Dexamethasone 1 mg		Dexamethasone 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Dexamethasone 1 mg		Dexamethasone 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/65 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Control		Dexamethasone 1 mg		Dexamethasone 4 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/65 (0%)		0/65 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.