Skip to main content
OpenTrials
Completed

NCT Number: NCT01586806

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Reconstruction Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Regional Anesthesia, Saphenous Nerve Block Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Patient-perceived Duration of Analgesia

    Time frame: 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 outcomes

  1. NRS (Numerical Rating Scale) Pain Scores

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 27, 2012
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.