- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07654556
Investigating the Analgesic Efficacy and Ease of Perfomance of Modified Throracoabdominal Plane Block and Comparing it With Erector Spinea Plane Block in Laparacopic Sleeve Gasterctomy Surgeries
Evaluating Analgesic Efficacy and Feasibility of Modified Thoracoabdominal Plane Block Compared With Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study
Interest in surgical weight loss interventions continues to rise in the face of what has been dubbed the obesity epidemic. The most popular of these weight loss interventions is laparoscopic sleeve gastrectomy, which has proven to reduce morbidity and mortality of morbidly obese patients. The aim of effective perioperative pain management extends beyond increased patient comfort and includes reduced recumbency period, enhanced recovery, reduced hospital stay, and lowers postoperative complication rates.
Effective postoperative pain management has traditionally relied on multimodal strategies that combine systemic opioids, non-opioid medications, and regional anesthesia. Despite their efficacy, opioids are associated with a range of undesirable effects, such as nausea, vomiting, sedation, pruritus, and respiratory depression, which may impede early mobilization and recovery. These concerns have accelerated the adoption of ultrasound-guided regional anesthesia techniques as part of Enhanced Recovery After Surgery (ERAS) protocols, delivering superior pain control with fewer systemic adverse effects.
연구 개요
상태
정황
상세 설명
Among the newer regional techniques described for thoracoabdominal analgesia are the Modified thoracoabdominal plane block through perichondrial approach (M-TAPA) block and the erector spinae plane (ESP) block. The visceral analgesic effect of ESPB appears inconsistent and may be limited by technical and anatomical factors. ESPB requires relatively deep needle placement at thoracic levels, and achieving reliable anterior spread of local anesthetic is highly operator dependent. These challenges may be exacerbated in obese patients undergoing bariatric surgery, in whom ultrasound visualization and needle control can be technically demanding. Furthermore, uncertainty regarding the mechanism and extent of visceral afferent blockade, along with concerns about potential complications related to deep paraspinal injection, may limit the reproducibility and routine clinical applicability of ESPB in this population.
In contrast, the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a more superficial and anatomically predictable technique designed to block thoracoabdominal nerves supplying the upper abdominal wall. Emerging evidence suggests that M-TAPA provides effective postoperative analgesia and opioid-sparing benefits in upper abdominal laparoscopic surgery, with a simpler and potentially safer technical profile compared with deeper regional techniques. Given its reduced operator dependency and technical simplicity, M-TAPA may represent an appealing alternative for patients undergoing laparoscopic sleeve gastrectomy. However, direct comparative evidence between ESPB and M-TAPA in this specific surgical context, particularly with respect to visceral pain control, remains lacking. Therefore, a randomized comparison of these two techniques is warranted.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hesham khedr Prof. Dr., Professor
- 전화번호: 02 01001622640
- 이메일: hkhishamkhedr@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients from both sexes.
- 18 to 60 years old.
- ASA physical status II-III scheduled for laparoscopic sleeve gastrectomy.
- Patients with BMI (40-50) kg/ m2
Exclusion Criteria:
- Patient Refusal
- Lack of patient cooperation.
- Patients with any contraindication to regional nerve blocks as coagulopathy or infection at site of injection
- Patients with anatomical abnormalities at site of injection
- Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
- Patients with pre-existing neurological disorder
- Patients with chronic pain syndromes including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
- Patients with history of long-acting opioids, steroids, anticonvulsants perioperatively.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Modified thoracoabdominal plane block through perichondrial approach (M-TAPA)
The M-TAPA block will be performed after induction of general anaethesia, with total volume of 25ml of 0.25% bupivacaine.
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A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided M-TAPA block.
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활성 비교기: Erector Spinea plane block (ESP block)
The ESP block will be performed after induction of general anaethesia , with total volume of 40 ml of 0.25% bupivacaine.
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A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided ESP block.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Visual Analogue Score
기간: 48 hours
|
Measurment of postoperative Visual Analogue Score, which is a scale from 0 to 10 in which 0 indicates no pain while 10 denotes unbearable pain, this will be done after 48 hours.
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48 hours
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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. .
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-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
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