Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?
Does Perineural Dexmedetomidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
연구 개요
상세 설명
Background:
Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.
Method:
On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded to volunteer and investigator.
The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Koege, 덴마크, 4600
- Department of Anesthesiology Koege 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 Heart block Sick sinus node.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ropivacaine + Dexmedetomidine
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml
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100 ug dexmedetomidine added to the ropivacaine nerveblock
다른 이름들:
20 ml Ropivacaine 5mg/ml
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위약 비교기: Ropivacaine + Placebo
Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline
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20 ml Ropivacaine 5mg/ml
Placebo
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab
기간: 0-36 hours
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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) Time for sleep will be provided.
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0-36 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick
기간: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
기간: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block.Time for sleep will be provided.
Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.
A Linear 100mm visual analogue scale (VAS) will be used.
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0-36 hours
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Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold
기간: 0-36 hours
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Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Time for sleep will be provided
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0-36 hours
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Difference between dexmedetomidine 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.
Time for sleep will be provided.
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
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0-36 hours
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Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.
기간: 0-36 hours
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Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values.
Time for sleep will be provided.
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0-36 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jakob H Andersen, MD, Department of Anesthesiology Koege Hospital
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
- SM2-JH-14
- 2014-005651-89 (EudraCT 번호)
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