Remote Controlled Analgesia on Patient Experience (R-CAPE)
Effect of Perineural Catheter Analgesia on Patient Experience After Orthopedic Surgery
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
연구 개요
상세 설명
Acute postoperative pain is poorly treated. More than three-quarters of patients complain of pain, from moderate to extreme, after surgery. In orthopedic surgery, continuous nerve blocks analgesia has proved effective among in-hospital patients but single injection strategy is easier to implement in the growing outpatient setting.
The main objective of this study is to compare the efficacy of continuous nerve blocks with single injection in terms of perioperative patient satisfaction after scheduled orthopedic ambulatory surgery. Subgroup analyses will be performed, a priori, according to patients Pain Catastrophizing Scale (PCS) and type of surgery.
Secondary objectives comprise the assessment of pain, readmission rates, patient mobilization, quality of sleep and heart rate collected by an activity tracker. Scales about quality of recovery will be performed on day 1, about quality of life on day 45 and presence of neuropathic pain will be screened at 3 months. An economic study will also be conducted, including work resumption at 3 months.
The inclusion criteria are adults undergoing outpatient scheduled orthopedic surgery under general anesthesia with regional analgesia.
Non-inclusion criteria are patients over 80 years, documented cognitive impairment, inability to complete a self-administered questionnaire, presenting American Society of Anesthesiology (ASA) physical status 3 unsteady or 4, or spontaneously requiring analgesic perineural catheter or a single injection of local anesthetics.
This is a multicentric prospective study. Three hundred patients will be randomized in two parallel groups: continuous nerve blocks delivered thru remote-controlled electronic pump versus single local anesthetics injection.
The primary endpoint is the EVAN-G patient satisfaction scale, scored at day 2. Secondary endpoints will include assessment of pain, opiates consumption, sensitivity and motricity scores, rate of catheter falls at home, hospital readmission, patient mobilization, sleep and heart rate as assessed by an activity tracker, PCS before the surgery and Quality of Recovery (QoR-40) scale at day 1, Short-Form 36 (SF36) at day 45 and Neuropathic Pain assessment (DN4) at day 90.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Montpellier, 프랑스, 34295
- Department of Anesthesiology and critical care, Lapeyronie University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female subject aged 18 or more, up to 80 years;
- Undergoing potentially painful scheduled orthopedic surgery under general anesthesia.
- Eligible to outpatient care;
Respecting the ambivalence clause defined below:
- no cons-indication to analgesic perineural catheter;
- not known allergy to local anesthetics;
- likely to be a candidate for continuous nerve block analgesia;
- Ability to complete a self-reported questionnaire;
- Have given written informed consent
Exclusion Criteria:
- Age less than 18 or more than 80 years;
- Pregnant or nursing women ;
- Not being affiliated to the social security scheme;
- Known allergy to local anesthetics of the amide type;
Regulatory constraints in the outpatient management of perineural catheters not respected:
- Inability of daily nursing care;
- No presence of a responsible adult at home the night of the intervention;
- Scheduled hospital stay;
- ASA physical status score (American Society of Anesthesiologists) above 3 or 3 unsteady;
- Spontaneous request for continuous nerve block or single injection;
- Topic unable to fulfill only a self-administered questionnaire (inability to read French, severe cognitive impairment);
- Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
- Topic treated with antipsychotics (neuroleptics or lithium);
- Subject has a documented chronic pain syndrome;
- Active consumer of narcotic topic;
- Topic have not signed informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Electronic pump
Continuous nerve blocks Remote-controlled perineural local anesthetics delivery
|
Remote-controlled perineural local anesthetics delivery
|
|
간섭 없음: single injection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient experience and satisfaction scale (EVAN-G)
기간: Second day after surgery
|
Description: Patient experience and satisfaction scale
|
Second day after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient quality of recovery (QoR)
기간: First day after surgery
|
Description: Patient quality of recovery
|
First day after surgery
|
공동 작업자 및 조사자
수사관
- 연구 의자: Xavier CAPDEVILA, M.D., Ph.D., University Hospital, Montpellier
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9677
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
정형외과에 대한 임상 시험
-
Sinai UniversityMenoufia University완전한
-
Karolinska Institutet초대로 등록TMD | TMJ - 측두하악 관절의 반월판 손상 | TMJ- Oral & amp; Maxillofacial Surgery스웨덴
-
National Taiwan University Hospital초대로 등록소아과 | 폐외과 | 수술 후 빠른 회복(Enhanced Recovery After Surgery, ERAS)대만
-
Assistance Publique Hopitaux De Marseille완전한심혈관 질환 | 비만 환자 | Bariatric Surgery 전후의 이러한 TRL의 생성률프랑스
-
Dong Yang알려지지 않은복강경 보조 수술 | 절개 없는 복강경 전수술(Natural Orifice Transluminal Endoscopic Surgery, NOSES)중국
-
Near East University, TurkeyAl-Ahli Hospital, Hebron모집하지 않고 적극적으로DVT 예방 | DVT - 심부 정맥 혈전증 | 심장 온펌프 수술 | DVT 예방 | On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications | 간호 관리 프로토콜키프로스
-
University Hospital, Strasbourg, France모병Cervico-Facial Surgery ENT 프랑스의 학술 의료 및 외과 교육 | Cervico-Facial Surgery ENT Medical 레지던트(Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine 및 Provence-Alpes-Côte d'Azur 지역)프랑스
-
King Abdulaziz University모병측두하악 장애(TMD) | TMJ 통증 | 미술치료 | TMJ- Oral & amp; Maxillofacial Surgery | 윌크스 1과 2 | TMD 예술 통증 연구사우디 아라비아