- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04419701
Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty
Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration for Postoperative Pain in Knee Arthroplasty
Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.
The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.
연구 개요
상세 설명
Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic department, has been a successful intervention for patients with end-stage knee arthritis.
Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain without motor impairment, resulting in successful mobilization. Pain control plays an essential role in the overall postoperative period for the patients undergoing TKA.
Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.
The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.
Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to evaluate functional recovery and the success of the type of analgesia used.
Several methods such as intravenous opioids, extraarticular and intraarticular injection, epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative pain management.
However, each method is reported with potential side effects, for example, opioid drugs caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia with urinary retention, respiratory depression and spinal headache, femoral or sciatic block with diminished muscle control and possible nerve damage.
Periarticular multimodal drug injection in TKA is a technique that patients received intraoperative drug injection in the periarticular fields such as posterior capsule, medial and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.
Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
El Gharbyia
-
Tanta, El Gharbyia, 이집트, 31527
- Tarek Abdel Hay
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- unilateral knee arthroplasty surgery,
- aged more than 50 years of both genders.
- have american society of anesthesiologist physical status I-II and III.
Exclusion Criteria:
- Revision knee arthroplasty,
- previous surgery or trauma to knee,
- drug allergy, regular narcotic use,
- renal impairments
- hepatic impairments,
- neuromuscular diseases
- coagulopathy disorders.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: periarticular infiltration group
will receive intraoperative periarticular infitration consisting of 89.5 mL of normal saline, 20 mL of 5% bupivacaine and 0.5 mL of adrenaline (4.5 ugm/ml) with a concentration 1:220000 (total volume: 110 mL)
|
The cocktail will be injected at the following 7 anatomical zones as follows: Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement. |
|
실험적: genicular nerve block group
will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% with adrenaline 2.5 µg/ml with a concentration 1:400000 in the immediate postoperative period.
|
The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound.
genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
total doses of postoperative opioid consumption
기간: postoperative first day
|
total doses of postoperative rescue morphine consumption
|
postoperative first day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time of the first dose of rescue analgesia
기간: postoperative first day
|
Time of the first dose of rescue morphine analgesia at dose of 3 mg
|
postoperative first day
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knee range of motion
기간: postoperative first day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative first day
|
|
Knee range of motion
기간: postoperative second day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative second day
|
|
Knee range of motion
기간: postoperative third day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative third day
|
공동 작업자 및 조사자
스폰서
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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)
periarticular infiltration에 대한 임상 시험
-
Ege University모집하지 않고 적극적으로충치 | 치아 탈회 | 법랑질에 국한된 매끄러운 표면의 충치 | 치과, 수술 | 충치 활동 테스트 | 캐리오그램칠면조
-
DMG Dental Material Gesellschaft mbH완전한