The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability
The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability. A Randomised, Blinded, Healthy Volunteer Study
The aim is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.
The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and nerve block duration will not increase further.
연구 개요
상세 설명
The trial is divided into two similar phases. Each phase will focus on a specific nerve. Phase 1 will focus on the common peroneal nerve and Phase 2 will focus on the sciatic nerve.
After baseline measurements, the investigators will insert a peripheral intravenous catheter. Then, the investigators will insert a suture-method peripheral nerve catheter (Certa CatheterTM). Procedures will be done in a sterile manner as a standard of practice. The investigators will use an ultrasound (US)-guided short-axis, needle in-plane technique. For the US-scan, the investigators will use a linear or a curvilinear transducer.
During interventions, volunteers will be monitored with continuous pulse oximetry. Placement of the peripheral nerve catheter will be facilitated by US using small injections of mepivacaine (carbocaine 2 %) in the skin and surrounding tissues and only isotonic saline (5 mL) in the perineural space to prevent blocking of the nerve before ropivacaine injection. The catheter orifice will be placed by pulling either end of the catheter and guided by the built-in echogenic markings seen on US. Before injection of ropivacaine, the investigators will do careful aspirations through the catheter in order to prevent intravasal injection.
Each ropivacaine injection will be administered via an infusion pump. This will ensure a constant infusion rate set to 10 mL per minute. During infusion, the volunteers will be monitored with continuous pulse oximetry.
Before instigation of the ropivacaine infusion, the investigators will use US to verify full absorption of the isotonic saline in the perineural space.
For each nerve, the subject will be randomly allocated to and receive one of five possible ropivacaine volumes. All volunteers and outcome assessors will be blinded to the ropivacaine administrations and infusion procedures. Outcome assessors will not be in the room, when the medication is prepared nor given. Preparation will take place behind a curtain and therefore also blinded to the volunteers.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
-
Hillerød, 덴마크, DK-3400
- Claus Behrend Christiansen
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria
- Male or female 18-64 years
- American Society of Anesthesiologists Classification ≤ II
Exclusion criteria
- Body Mass Index ≤ 18 or ≥ 30
- Former surgery to the lower extremities
- Peripheral nerve disease
- Allergy to ropivacaine
- Pregnancy or breastfeeding
- Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
- Habitual use of any kind of analgesic treatment
- Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Peroneal nerve: Ropivacaine 0.2%, 2.5 mL
Perineural injection of ropivacaine 0.2 %, 2,5 mL
|
Perineural injection.
|
|
활성 비교기: Peroneal nerve: Ropivacaine 0.2%, 5 mL
Perineural injection of ropivacaine 0.2 %, 5 mL
|
Perineural injection.
|
|
활성 비교기: Peroneal nerve: Ropivacaine 0.2%, 10 mL
Perineural injection of ropivacaine 0.2 %, 10 mL
|
Perineural injection.
|
|
활성 비교기: Peroneal nerve: Ropivacaine 0.2%, 15 mL
Perineural injection of ropivacaine 0.2 %, 15 mL
|
Perineural injection.
|
|
활성 비교기: Peroneal nerve: Ropivacaine 0.2%, 20 mL
Perineural injection of ropivacaine 0.2 %, 20 mL
|
Perineural injection.
|
|
활성 비교기: Sciatic nerve: Ropivacaine 0.2%, 5 mL
Perineural injection of ropivacaine 0.2 %, 5 mL
|
Perineural injection.
|
|
활성 비교기: Sciatic nerve: Ropivacaine 0.2%, 10 mL
Perineural injection of ropivacaine 0.2 %, 10 mL
|
Perineural injection.
|
|
활성 비교기: Sciatic nerve: Ropivacaine 0.2%, 15 mL
Perineural injection of ropivacaine 0.2 %, 15 mL
|
Perineural injection.
|
|
활성 비교기: Sciatic nerve: Ropivacaine 0.2%, 20 mL
Perineural injection of ropivacaine 0.2 %, 20 mL
|
Perineural injection.
|
|
활성 비교기: Sciatic nerve: Ropivacaine 0.2%, 30 mL
Perineural injection of ropivacaine 0.2 %, 30 mL
|
Perineural injection.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Duration of sensory nerve block
기간: 1-24 hours
|
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve.
Testing will start after onset of sensory nerve block and continue until normal sensation has returned.
When testing the sciatic nerve, we will continue testing until normal sensation has returned in both components of the nerve, i.e. the tibial and common peroneal nerve.
|
1-24 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of nerve exposed to local anaesthesia
기간: 10 minutes
|
We will measure local anaesthetic spread in a proximal-to-distal manner parallel to the nerve trajectory.
Total length of the neural spread will be reported in millimetres from the most proximal point to the most distal point in which fluid, i.e. ropivacaine, is seen on ultrasound in proximity to the nerve.
Testing will be done immediately after end of ropivacaine infusion.
|
10 minutes
|
|
Onset of sensory nerve block
기간: 10-180 minutes
|
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve.
Testing will start ten minutes after end of infusion and continue for every fifth minute until onset.
We will test for a maximum of 180 minutes.
|
10-180 minutes
|
|
Onset of motor nerve block
기간: 10-180 minutes
|
Testing will start ten minutes after end of infusion and continue for every fifth minute until onset.
When onset of sensory nerve block is confirmed, testing of motor nerve block onset will end as well, if not already found.
Motor nerve block of the tibial nerve will be evaluated by plantarflexion of the ankle.
Motor nerve block of the common peroneal nerve will be tested by dorsiflexion of the ankle.
|
10-180 minutes
|
|
Degree of sensory nerve block
기간: 1-24 hours
|
We will test sensory nerve block using a subjective rating scale.
We will grade from one to four: 1) "not different from ipsilateral antebrachium"; 2) "different from ipsilateral antebrachium"; 3) "warm sensation"; 4) "no sensation".
Grades 2-4 will be considered as successful sensory nerve blocks.
It will be noted if the volunteer is in doubt.
Nevertheless, this will be considered as a successful sensory nerve block and graded as 2) in the post hoc statistical analyses.
|
1-24 hours
|
|
Degree of motor nerve block
기간: 1-24 hours
|
This will be tested with the volunteer in the upright position using a sturdy counter for balance if necessary.
Motor strength will be evaluated using a normal everyday activation of the lower leg: A toe and a heel raise, testing the common peroneal nerve via activation of the anterior tibial muscle and the tibial nerve via activation of the gastrocnemius muscle, respectively.
Motor nerve block intensity will be evaluated on a scale from one to three: 1) normal strength, 2) paresis or 3) paralysis.
Volunteers will be asked to perform a maximum contraction building up muscle force over three seconds.
It will be noted if the volunteer is in doubt, which will be considered as 2) paresis in the post hoc statistical analyses.
|
1-24 hours
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Kai Henrik Wiborg Lange, MD DMSC, Nordsjællands Hospital Hillerød
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-16000184
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
수술 후 통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Ropivacaine에 대한 임상 시험
-
Poznan University of Medical Sciences모병
-
Institut CurieNational Cancer Institute, France완전한
-
University of British Columbia모병
-
Virginia Commonwealth University빼는