Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
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Hellerup
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Gentofte, Hellerup, 덴마크, 2900
- Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Exclusion Criteria:
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
- Alcohol or drug abuse
- Daily intake of opioids or steroids last 4 weeks
- Daily intake of any analgesics last 48 hours
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Ropivacaine + dexamethasone
20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml
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Adductor canal block, single bolus
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위약 비교기: Ropivacaine + placebo
20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad
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Adductor canal block, single bolus
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
기간: 0-36 hours
|
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.
|
0-36 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick
기간: 0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
|
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
기간: 0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value. |
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold
기간: 0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. |
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold
기간: 0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. |
0-36 hours
|
|
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation
기간: 0-36 hours
|
Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.
|
0-36 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pia Jæger, MD, PhD, Rigshospitalet, Denmark
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- SM2-PJ-14
- 2014-004879-23 (EudraCT 번호)
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