Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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California
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San Francisco, California, 미국, 94158
- University of California San Francisco
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment
Exclusion Criteria:
- Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Continuous epidural infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
다른 이름들:
다른 이름들:
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실험적: Programmed intermittent epidural bolus
For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
다른 이름들:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total Local Anesthetic Utilized in First 24 Hours
기간: In first 24 hours
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Total local anesthetic consumed while epidural in place, recorded on infusion pump
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In first 24 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total Opioid Consumed
기간: While epidural in place (up to 72 hours post operatively)
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Total opioid consumed (intravenous or po) while epidural in place
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While epidural in place (up to 72 hours post operatively)
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Patient Satisfaction Score
기간: While epidural in place (up to 72 hours postoperatively)
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Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction. |
While epidural in place (up to 72 hours postoperatively)
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Average Pain Severity
기간: While epidural in place (up to 72 hours postoperatively)
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Measured by modified pain inventory on a daily basis while epidural in place.
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
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While epidural in place (up to 72 hours postoperatively)
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Incidence of Hypotension
기간: While epidural in place (24 hours postoperatively)
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Most common side effect post-operatively with epidural anesthesia.
Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
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While epidural in place (24 hours postoperatively)
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Worst Reported 24 Hour Pain
기간: While epidural in place (up to 72 hours postoperatively)
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Minimum is 0, maximum is 10. 10 indicates highest pain severity.
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While epidural in place (up to 72 hours postoperatively)
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Average Pain Interference
기간: While epidural in place (up to 72 hours postoperatively)
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Minimum is 0, maximum is 10. 10 indicates highest pain interference.
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While epidural in place (up to 72 hours postoperatively)
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 15-18354
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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