Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia
Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye)
- İstanbul Medipol University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Exclusion Criteria:
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
- Presence of neurological disease.
- Refusal to participate in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group QLB
Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
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|
실험적: Group TFP
Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery.
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Bilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
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활성 비교기: Group Control
Patients will receive only port site infiltration at the end of the surgery.
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Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numeric Rating Scale (NRS) Pain Score
기간: At 0, 3, 6, 12, 18, and 24 hours postoperatively.
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Postoperative pain intensity assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Higher scores represent worse pain outcomes.
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At 0, 3, 6, 12, 18, and 24 hours postoperatively.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Tramadol Consumption
기간: During the first 24 hours postoperatively.
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The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.
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During the first 24 hours postoperatively.
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Need for Rescue Analgesia
기간: During the first 24 hours postoperatively
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The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.
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During the first 24 hours postoperatively
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Incidence of Opioid-Related Side Effects
기간: During the first 24 hours postoperatively.
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The number of patients experiencing postoperative nausea, vomiting, or sedation.
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During the first 24 hours postoperatively.
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Incidence of Block-Related Complications
기간: During the first 24 hours postoperatively.
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The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).
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During the first 24 hours postoperatively.
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- İnguinal QLB vs TFP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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