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Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES) (EPAPRES)

2018년 8월 21일 업데이트: Derya Ozden Omaygenc, Yedikule Training and Research Hospital

Comparison of Thoracic Epidural and Intravenous Analgesia From the Perspective of Recovery of Respiratory Function at Early Post-thoracotomy Period in Lung Cancer Surgery

Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

lung cancer patients (between ages 18 to 75 and American Society of Anesthesiologists -ASA- Class I to III), undergoing an elective thoracic surgical procedure with posterolateral thoracotomy, were enrolled. The study was approved by the local ethical committee in Yedikule Chest Diseases and Thoracic Surgery Ed. and Research Hospital and therefore had been performed in accordance with global ethical standards. Written informed consent was received from all participants.

Individuals beyond defined age limits, patients who have psychiatric problems, auditory deficit, drug abuse, severe cardiovascular system disorders or severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume were excluded. Patients refusing to give consent and to whom inserting an epidural catheter is contraindicated were not involved either. Surgical procedures were performed by the same team. In the operating room, if serratus anterior muscle could not be spared or chest wall resection was performed, these patients were also excluded even though they had met other qualifications. Finally, patients who could not be extubated before transfer were not involved.

Regarding pre-operative evaluation, age, gender, weight, height, smoking status (package/years) and ASA score of patients were recorded.

For assessing the impact of method of analgesia on target parameters, patients were allocated to TEA and intravenous analgesia (IVA) groups. Randomisation was performed by closed envelope method.

2.2 Features of anesthetic technique and intraoperative analgesia Before the initiation of procedure, in TEA group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of a 18 G Thuohy needle (Pajunk, Geisingen, Germany) while patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintanence was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Anesthesia was induced with midazolam (0.04 mg/kg), propofol (2 mg/kg) and fentanyl (1mcg/kg) in both groups and the neuromuscular blockage was provided with cisatracurium besilate (0,2 mg/kg). Then, insertion of a double-lumen tracheal tube was performed. After standard patient positioning, localization of the tube was checked with a fiberoptic bronchoscope. Pressure controlled ventilation was used (Primius, Drager, Luebeck, Germany) and invasive arterial pressure, electrocardiography, arterial blood gas analysis, end-tidal carbon dioxide concentration, central venous pressure and urine output were closely monitored in the operating room. Hypothermia was avoided with the help of a warming system and body temperature was kept over 36°C. In TEA group, absolute intraoperative analgesia was warranted with 0,5-2 MAC sevoflurane. In IVA group, remifentanyl infusion (0.1-0.2 mcg/kg/min) was additionally used for this purpose. If arterial pressure exceeds a value of 20% or more of baseline recordings, 1 mcg/kg fentanyl was administered. Every one hour, an additional dose (0.25 mg/kg) of cisatracurium besilate was administered to ensure complete myorelaxation.

The intercostal blockage was applied by the surgical team to the entire population before closing the wound by injecting 4 ml of 0.25% bupivacaine to the region of incision and two intercostal regions above and below the incision site. Once closure was started, morphine sulphate (0,1 mg/kg), tramadol (100 mg), paracetamol (100 mg) and tenoxicam (20 mg) was given intravenously. Anterior 28 Ch and posterior 32 Ch drainage tubes were inserted to the patients to whom lobectomy or bilobectomy was performed. For pneumectomy, only posterior 32 Ch tube was placed. After reversal of neuromuscular blocking agents, patients with adequate spontaneous ventilation and verbal response were transferred to the critical care unit.

Regarding to peri-operative data, procedure time, type of the operation (lobectomy or pneumectomy), duration of tube drainage and presence of operation related complications were recorded.

Visual Analogue Score (VAS) was used to estimate the severity of pain. A score of 0 cm represented "no pain at all" and 10 cm did "intractable pain" so.

연구 유형

중재적

등록 (실제)

62

단계

  • 해당 없음

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • American Society of Anesthesiologists -ASA- Class I to III)
  • Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy

Exclusion Criteria:

  • Individuals beyond defined age limits
  • Having psychiatric problems
  • Having an auditory deficit
  • Active drug abuse
  • Severe cardiovascular system disorders
  • Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
  • Refusing to give consent
  • Contraindication to insertion of an epidural catheter.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Thoracic Epidural Analgesia
Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.
Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.
다른 이름들:
  • Posterolateral thorachotomy
  • Intercostal blockade
In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.
다른 이름들:
  • Pethidine intravenous infusion
활성 비교기: Intravenous analgesia
Population to whom combined intravenous analgesia was administered.
Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.
다른 이름들:
  • Posterolateral thorachotomy
  • Intercostal blockade

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Postoperative FEV1 and FVC alterations
기간: 3 days
Comparison of preoperative and postoperative FEV1 (liters, %) and FVC.(liters, %)
3 days

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative pH alteration
기간: 24 hours
pH value at 1st and 24th postoperative hours were compared
24 hours
Postoperative pO2 alteration
기간: 24 hours
pO2 (mmHg) value at 1st and 24th postoperative hours were compared
24 hours
Postoperative pCO2 alteration
기간: 24 hours
pCO2 (mmHg) value at 1st and 24th postoperative hours were compared
24 hours
Postoperative HCO3 concentration alteration
기간: 24 hours
Bicarbonate concentration (mEq/dL) at 1st and 24th postoperative hours were compared
24 hours

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

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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)

2015년 8월 1일

기본 완료 (실제)

2017년 8월 1일

연구 완료 (실제)

2018년 3월 1일

연구 등록 날짜

최초 제출

2018년 8월 16일

QC 기준을 충족하는 최초 제출

2018년 8월 21일

처음 게시됨 (실제)

2018년 8월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 21일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2866

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

Can be provided on request

IPD 공유 기간

1 week

IPD 공유 액세스 기준

E-mail

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF
  • CSR

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. .

호흡 장애에 대한 임상 시험

Thoracic epidural analgesia에 대한 임상 시험

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