Fixed-Mass Different Volumes Bupivacaine TAP Block After Cesarean
Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section Using Two Different Bupivacaine Volumes With a Fixed Drug Mass. A Randomized Comparative Trial.
Cesarean section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of peripheral nerve blocks such as the transversus abdominis plane block.
The TAP block is a fascial plane block that provides analgesia by depositing local anaesthetic between the internal oblique and transversus abdominis muscles. Its efficacy after cesarean section has been demonstrated, particularly when long-acting intrathecal opioids are not used. However, the optimal local anaesthetic volume and dose remain unclear. Since the TAP block depends on adequate spread of local anaesthetic, larger volumes may improve analgesic coverage, but increasing the dose may raise the risk of systemic toxicity.
Therefore, this study investigates whether using the same fixed mass of bupivacaine in two different volumes affects the analgesic efficacy of TAP block after cesarean section, hypothesising that the larger volume may provide better postoperative analgesia.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Abeer Ahmed, MD
- 전화번호: +201005244590
- 이메일: abeer_ahmed@kasralainy.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- full-term parturients,
- aged > 18 years
- ASA physical status II
- patients who are scheduled for elective CS with Pfannenstiel incisions under spinal anaesthesia.
Exclusion Criteria:
- Parturients with contraindications to spinal anaesthesia,
- Having a scar or infection at the site of the block
- BMI > 35 Kg/m2,
- on chronic use of pain medications,
- Refusing to participate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Fixed-mass, high-volume bupivacaine TAP block
Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 60 mL, injected as 30 mL per side.
|
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side.
|
|
실험적: Fixed-mass, low-volume bupivacaine TAP block
Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 120 mL, injected as 60 mL per side.
|
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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total postoperative morphine consumption
기간: first 24 hours postoperatively
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first 24 hours postoperatively
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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. .