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

NCT01586806 | Completed Phase 4 Results DMC

• 1 other identifier: IRB #2012-002
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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. 1.13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
2. 2.13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
3. 3.13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.

Conditions

Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, Saphenous Nerve Block

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Patient-perceived Duration of Analgesia

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

  Up to 2 days following surgery

Secondary Outcomes (4)

• NRS (Numerical Rating Scale) Pain Scores

  Postoperative day 1

• Patient Satisfaction

  Up to 2 days following surgery

• Postoperative Morphine Consumption

  Up to 2 days following surgery

• Opioid-Related Side Effects (Drowsiness)

  Up to 2 days following surgery

Study Arms (3)

Control

PLACEBO COMPARATOR

Drug: Bupivacaine Only

Dexamethasone 1 mg

ACTIVE COMPARATOR

Drug: Bupivacaine with 1 mg of Dexamethasone

Dexamethasone 4 mg

ACTIVE COMPARATOR

Drug: Bupivacaine with 4 mg of Dexamethasone

Interventions

Bupivacaine Only DRUG

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).

Control

Bupivacaine with 1 mg of Dexamethasone DRUG

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.

Dexamethasone 1 mg

Bupivacaine with 4 mg of Dexamethasone DRUG

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.

Dexamethasone 4 mg

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (6)

• 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.

  PMID: 20009936 BACKGROUND

• 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.

  PMID: 21676892 BACKGROUND

• 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. doi: 10.1016/0959-8049(94)90182-1.

  PMID: 7999421 BACKGROUND

• 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.

  PMID: 15333398 BACKGROUND

• Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.

  PMID: 17005509 BACKGROUND

• Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates 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.

  PMID: 18574578 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pain; Nausea; Vomiting

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Mary Chisholm
• Organization: Hospital for Special Surgery

chisholmm@hss.edu

2126061206

Study Officials

• Mary F. Chisholm, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 28, 2016
• Results First Posted: June 9, 2016

Record last verified: 2016-08

Locations

US (1)