- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01586806
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL 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:
- 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
- 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
- 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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10021
- Hospital for Special Surgery
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 제어
|
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).
|
|
활성 비교기: Dexamethasone 1 mg
|
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.
|
|
활성 비교기: Dexamethasone 4 mg
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-perceived Duration of Analgesia
기간: 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.
|
Up to 2 days following surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
NRS (Numerical Rating Scale) Pain Scores
기간: 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.
|
Postoperative day 1
|
|
Patient Satisfaction
기간: 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);
|
Up to 2 days following surgery
|
|
Postoperative Morphine Consumption
기간: Up to 2 days following surgery
|
Data collector will record how many opioids (i.e.
Percocet, Vicodin) the patient has used since discharge.
|
Up to 2 days following surgery
|
|
Opioid-Related Side Effects (Drowsiness)
기간: 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.
|
Up to 2 days following surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mary F. Chisholm, MD, Hospital for Special Surgery, New York
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB #2012-002
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .