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Ultrasound Guided Bilateral Erector Spinae Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

2020년 6월 10일 업데이트: Amany Faheem, Tanta University
Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).(6) The available evidence indicates that erector spinae block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics

연구 개요

상세 설명

-Preoperative: Evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigation and patients will be trained to use the Numerical Rating Scale (NRS 0= no pain, 10= intolerable pain) used for evaluation of pain intensity.

The patient is allowed to fast for 8 hours for solids and 2h for clear fluid. Before the study, all patients will be interviewed and will be briefed on the wake-up test procedure. They will be informed that they will be asked to open their eyes, move their fingers (hold the anesthesiologist's hand), move their toes, and finally, to remember a given color.

-Intraoperative: On arrival to operating roome, a 20 G peripheral IV cannula will be inserted. Electrocardiogram (ECG), noninvasive mean arterial blood pressure (MAP) and peripheral oxygen saturation will be attached and baseline data will be monitored and documented. Sedation will be given intravenously in the form of midazolam 0.02 mg/kg and IV fliud according to calculation of deficit and maintaince calculation.

After preoxygenation, anesthesia with IV propofol 2 mg/ kg and fentanyl 2 µg/kg will be administered for analgesia and cisatracurium 0.5 mg/ kg will be given intravenously to facilitate endotracheal intubation.

Central venous catheter will be inserted and attached for monitoring of CVP. Also, enotropy will be connected on the patientꞌs forehead and maintained between 40-60.

40 patients will be equally divided to two equal groups (20 patients for each group) Group 1: will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.

Group 2: will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position.

Maintaince of anaesthesia will be 50 : 50 % O2 to air and sevoflurane 2% and cisatracurium incremental every 30 min at dose of 0.1 mg/kg. I.V analgesia in form of incremental fentanyl 1 ug /kg when entropy increases more than 60 during surgery and 30 min before the wake-up test.

Wake up test: Before continuation of anesthesia, patients will be given a color to remember. After finishing the wake-up test, anesthesia will be induced using 3 mg/kg propofol and 0.1 mg/kg cisatracurium, whereas anesthesia will be maintained as described previously.

At the end of surgery, inhalational anesthetic agent will be turned off, residual neuromuscular block will be reversed with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg then patients will be extubated and will be transferred to post anesthesia care unit (PACU).

Postoperative multimodal analgesia: will received paracetamol 10 mg/kg every 6 hours and intravenous diclofenac 1.5 mg/kg every 8 hours regularly.

All observations will be carried out by a single investigator, who is blinded to the study groups.

-In all groups, the following will be measured: -

  1. Demographic data.
  2. Total doses of postoperative morphine consumption.
  3. Time of the first dose of rescue analgesia (morphine at dose of 0.1 mg/kg).
  4. Number of patients received rescue analgesia.
  5. Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 0.1 mg/kg will be given till NRS decreases to ≤3. NRS will be assessed and recorded on arrival to the Recovery Unit, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
  6. Total doses intraoperative consumption of fentanyl.
  7. Wake-up profile: On the surgeons' request for the intraoperative wake-up test, administration of sevoflurane will be stopped. (the quality of wake-up, return of spontaneous breathing, ability to open eyes on command, and ability to move hands and feet) and postoperative amnesia. Patients will be asked repeatedly during the wake-up test, at least every 15 s, to open their eyes and to move their hands and feet. The time elapsed from the interruption of anesthesia to the start of spontaneous breathing (T1), from the return of spontaneous breathing to eye opening on command (T2), and from eye opening to movement of hands and feet (T3) will be recorded in seconds using a stopwatch. The quality of the wake-up test will be evaluated on a three-point rank scale (8).
  8. First time of postoperative mobilization.

연구 유형

중재적

등록 (예상)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Tanta, 이집트
        • 모병
        • tarek Abdel Lattif

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

10년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • patients with idiopathic adolescent scoliosis undergoing surgical correction.

Exclusion Criteria:

  • Bleeding disorders (coagulopathy).
  • Mental dysfunction.
  • History of allergy to local anesthetics.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
가짜 비교기: control group
will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
using 1 mg /kg normal saline
실험적: erector spinae block
will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position
부피바카인
will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
postoperative morphine consumption
기간: within 24 hours postoperative
postoperative morphine consumption
within 24 hours postoperative

2차 결과 측정

결과 측정
측정값 설명
기간
수술 중 펜타닐 소비
기간: 수술 중
수술 중 펜타닐 소비
수술 중
time to first analgesic request
기간: within 24 hours postoperative
time to first analgesic request
within 24 hours postoperative

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 4월 4일

기본 완료 (예상)

2021년 3월 31일

연구 완료 (예상)

2021년 4월 1일

연구 등록 날짜

최초 제출

2020년 4월 3일

QC 기준을 충족하는 최초 제출

2020년 4월 6일

처음 게시됨 (실제)

2020년 4월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 6월 10일

마지막으로 확인됨

2020년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

부피바카인에 대한 임상 시험

3
구독하다