Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Comparison of the Analgesic Efficacy of Lateral Quadratus Lumborum Block and Intrathecal Morphine for Postoperative Pain Management Following Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Effective postoperative analgesia following cesarean delivery is essential not only for improving maternal comfort but also for facilitating early mobilization, breastfeeding, and maternal-infant bonding. Inadequate pain control has been associated with delayed mobilization, pulmonary complications, postpartum depression, and the development of chronic postsurgical pain (CPSP).
Intrathecal morphine (ITM) has long been regarded as the gold standard for post-cesarean analgesia, providing effective pain relief for 18-24 hours after a single dose. However, its use is limited by opioid-related adverse effects, including pruritus, postoperative nausea and vomiting (PONV), sedation, and urinary retention. These adverse effects may reduce maternal satisfaction and negatively affect breastfeeding and early mobilization.
In recent years, quadratus lumborum block (QLB) has emerged as an effective alternative for postoperative analgesia in abdominal surgery. Among the various QLB approaches, the lateral QLB-I technique has attracted considerable interest because of its ease of ultrasound-guided application, low incidence of motor block, and potential to provide extensive visceral and somatic analgesia. Previous studies have demonstrated that QLB can effectively attenuate both somatic and visceral pain, with cranial spread of local anesthetic along the thoracolumbar fascia reaching the ventral rami of the thoracic nerves (Blanco, 2015; Elsharkawy, 2019).
Randomized controlled trials in patients undergoing cesarean delivery have shown that QLB reduces postoperative opioid consumption, lowers pain scores, and improves patient satisfaction compared with control groups (Salama, 2020; Zhu, 2021). However, studies directly comparing QLB with ITM remain limited. Current evidence suggests that the analgesic efficacy of QLB may be comparable to that of ITM, although robust evidence demonstrating non-inferiority is still lacking.
Compared with ITM, the principal advantages of lateral QLB include the absence of motor blockade, the potential to reduce opioid-related adverse effects, and facilitation of early mobilization. Although ITM provides potent analgesia, demonstrating that the analgesic efficacy of lateral QLB is clinically equivalent within a non-inferiority margin not exceeding 10 mg intravenous morphine milligram equivalents (IV-MME) would represent a clinically acceptable outcome in terms of patient comfort and safety.
Accordingly, the primary objective of this study is to determine whether lateral QLB-I provides non-inferior postoperative analgesia compared with ITM. Secondary objectives include a comprehensive evaluation of adverse effects, quality of recovery using the ObsQoR-11T, and postoperative opioid consumption.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Burhan Dost
- 전화번호: +903623121919
- 이메일: burhandost@hotmail.com
연구 연락처 백업
- 이름: Esra Turunc
- 전화번호: +903623121919
- 이메일: esra.kiymaz.ek@gmail.com
연구 장소
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Samsun, 터키 (Türkiye)
- Ondokuz Mayis University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women aged between 18 and 45 years.
- Singleton term pregnancy (≥37 weeks of gestation).
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled to undergo elective cesarean delivery via a Pfannenstiel incision.
- Planned to receive spinal anesthesia for cesarean delivery.
- Provision of written informed consent following a comprehensive explanation of the study.
- Sufficient cognitive capacity to understand and complete the study assessment instruments, including the Numeric Rating Scale (NRS) and the ObsQoR-11T.
Exclusion Criteria:
- Known allergy or hypersensitivity to any of the study medications, including morphine, bupivacaine, or fentanyl.
- Coagulopathy (international normalized ratio [INR] >1.5 or platelet count <100,000/mm³).
- Current treatment with anticoagulant or antiplatelet agents (e.g., heparin, low-molecular-weight heparin, or aspirin >100 mg/day).
- Infection, hematoma, or skin lesion at the planned block insertion site.
- Diagnosis of preeclampsia, eclampsia, or HELLP syndrome.
- Placenta previa, placenta accreta spectrum, or placental abruption.
- Gestational diabetes mellitus or chronic hypertension.
- Emergency cesarean delivery indicated because of fetal distress.
- Conversion to general anesthesia during cesarean delivery.
- History of chronic pain syndrome (e.g., fibromyalgia, lumbar disc herniation, or neuropathic pain).
- Regular use of opioids or psychotropic medications within the preceding 3 months.
- Diagnosis of epilepsy, severe anxiety disorder, or major depressive disorder.
- Obesity (body mass index >35 kg/m²).
- Severe systemic disease, including New York Heart Association (NYHA) class III or IV heart failure, hepatic or renal failure, advanced respiratory disease, or obstructive sleep apnea.
- Advanced pulmonary disease requiring continuous positive airway pressure (CPAP) therapy.
- Inadequate spinal anesthesia or the requirement for supplemental intraoperative analgesia.
- Surgical duration exceeding 120 minutes.
- Excessive intraoperative blood loss (≥1,000 mL) or the need for blood transfusion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group QLB
LQLB (Active) + Sham ITM
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표준화 된 IV PCA 프로토콜은 PCA 장치 (Body Guard 575 Pain Manager, UK)를 사용하는 모든 환자에 대해 시작될 것입니다.
6 분짜리 잠금 및 4 시간 최대 복용량이 0.1-0.15 인 Mg/kg (IBW)
mg/ kg (IBW).
기초 주입이 사용되지 않습니다.
다른 이름들:
Active Lateral QLB Local anesthetic: 0.25% bupivacaine, 0.4 mL/kg perside (maximum 30 mL per side). Maximum total dose: Bupivacaine ≤2.5 mg/kg (maximum approximately 150 mg). Timing: Immediately after completion of surgery. The patient will be positioned supine or in a slight lateral decubitus position. A high-frequency linear US transducer (5-12 MHz) will be placed on the anterolateral abdominal wall at the T12-L1 level. The fascial plane will be identified under ultrasound guidance. A 22-gauge, 100-mm needle will be advanced using an in-plane approach, and after negative aspiration, the local anesthetic will be injected incrementally with hydrodissection confirming correct spread. Sham ITM: The spinal anesthesia technique will be identical to that of the active ITM group. Morphine will be replaced with 0.2 mL preservative-free normal saline, while maintaining an identical syringe volume (2.7 mL) and appearance.
다른 이름들:
|
|
실험적: Group ITM
ITM (Active) + Sham QLB
|
표준화 된 IV PCA 프로토콜은 PCA 장치 (Body Guard 575 Pain Manager, UK)를 사용하는 모든 환자에 대해 시작될 것입니다.
6 분짜리 잠금 및 4 시간 최대 복용량이 0.1-0.15 인 Mg/kg (IBW)
mg/ kg (IBW).
기초 주입이 사용되지 않습니다.
다른 이름들:
Hyperbaric 0.5% bupivacaine 12.5 mg, fentanyl 20 µg, and morphine 80 µg (0.08 mg). Spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle. The study solution will be prepared to a total volume of 2.7 mL. Sham QLB Following completion of surgery, the patient will be positioned in the lateral decubitus position. The ultrasound transducer will be placed over the lateral QLB scanning window. A 22-gauge needle will be advanced into the skin and subcutaneous tissue only, without entering the fascial plane. To maintain procedural standardization and preserve blinding, 1-2 mL of normal saline will be injected into the subcutaneous tissue. Procedure duration, patient positioning, ultrasound probe placement, and dressing application will be identical to those used for the active lateral QLB-I procedure. A sterile dressing will be applied at the end of the procedure.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative equivalent morphine consumption in the first 24 hours after surgery
기간: postoperative day 1
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The total dose of morphine administered via the patient-controlled analgesia (PCA) device, together with all rescue opioids administered during the first 24 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.
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postoperative day 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative equivalent morphine consumption in the first 48 hours after surgery
기간: postoperative day 2
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The total dose of morphine administered via the patient-controlled analgesia (PCA) device, together with all rescue opioids administered during the first 48 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.
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postoperative day 2
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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첫 번째 진통제 요청 시간
기간: 수술 후 1일
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첫 번째 진통제가 요구되는 시간
|
수술 후 1일
|
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구조진통제가 필요한 환자 수
기간: 수술 후 1일
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구조 진통제가 필요한 환자 수는 24시간에 걸쳐 기록됩니다.
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수술 후 1일
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Cumulative equivalent morphine consumption in the first 12 hours after surgery
기간: postoperative day 1
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The total dose of morphine administered via the patient-controlled analgesia (PCA) device, together with all rescue opioids administered during the first 12 postoperative hours following surgery, will be converted to morphine milligram equivalents (MME) using validated conversion factors and summed.
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postoperative day 1
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Postoperative pain scores
기간: postoperative day 2
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Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 24,36 and 48.
hours after surgery.
The NRS is an 11-point numeric scale that ranges from 0 to 10.
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postoperative day 2
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area under the NRS score curve (AUC) for resting
기간: postoperative day 2
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area under the NRS score curve (AUC) for resting and active 48 hours after surgery
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postoperative day 2
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Integrated Analgesic Score
기간: postoperative day 2
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Composite outcome integrating pain burden (AUC) and opioid consumption (IV-MME), expressed as the Integrated Analgesia Score (IAS), with lower scores indicating better overall analgesic efficacy.
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postoperative day 2
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Effective Analgesic Score
기간: postoperative day 2
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The Integrated Analgesia Score (IAS) will be calculated by jointly evaluating the mean pain scores (NRS, 0-10) and cumulative intravenous morphine milligram equivalent (IV-MME, mg) consumption over the 0-48-hour postoperative period.
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postoperative day 2
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ObsQoR-11T (Obstetric Quality of Recovery) score
기간: postoperative day 2
|
A validated patient-reported outcome measure assessing the quality of postoperative recovery after cesarean delivery.
The questionnaire consists of 11 items evaluating pain, physical comfort, physical independence, emotional state, and the ability to care for the newborn, with higher scores indicating better quality of recovery.
Scores range from 0 to 110, with higher scores indicating better recovery.
Assessments will be performed preoperatively (baseline) and at 24 and 48 hours postoperatively.
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postoperative day 2
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The number of patients requiring postoperative antiemetics.
기간: postoperative day 2
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The number of patients requiring treatment and PONV scores will be recorded in the post-anesthesia care unit (PACU) and at 3, 6, 12, 24, 36, and 48 hours postoperatively.
PONV will be assessed using a 4-point scale: 0 = no nausea or vomiting; 1 = mild nausea; 2 = one episode of vomiting; and 3 = more than one episode of vomiting.
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postoperative day 2
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The incidences of post-operative pruritus
기간: postoperative day 2
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The presence and severity of pruritus will be assessed using a four-point scale where 0 indicates no pruritus, 1 indicates mild pruritus, 2 indicates moderate pruritus, and 3 indicates severe pruritus.
A score of ≥1 will be considered the presence of pruritus.
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postoperative day 2
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Sedation score
기간: postoperative day 2
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Sedation levels will be assessed using the Pasero Opioid-Induced Sedation Scale (POSS) and recorded during the first 48 postoperative hours in the post-anesthesia care unit (PACU) and at 3, 6, 12, 24, 36, and 48 hours postoperatively.
Sedation will be graded as follows: S = awake and alert; 1 = slightly drowsy, easily aroused; 2 = frequently drowsy, easily aroused, drifts off to sleep during conversation; 3 = somnolent, difficult to arouse; and 4 = minimal or no response to verbal or physical stimulation.
Opioid-induced sedation will be defined as a POSS score ≥3 or a respiratory rate <8 breaths/min.
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postoperative day 2
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The incidences of Urinary retention
기간: postoperative day 2
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Number of patients with urinary retention (defined as failure to achieve spontaneous voiding within 8 hours after Foley catheter removal)
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postoperative day 2
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The morbidity of patients
기간: Postoperative 1 month on an average
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The patients comorbidities will be assessed using the Charlson Comorbidity Index
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Postoperative 1 month on an average
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The number of patients with complications
기간: Postoperative 1 month on an average
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The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
|
Postoperative 1 month on an average
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Delayed onset of lactation
기간: postoperative day 2
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Delayed onset of lactation will be defined as the maternal report of milk coming in (based on subjective breast fullness and the transition from colostrum to mature milk) occurring more than 48 hours after delivery.
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postoperative day 2
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Apgar scores
기간: postoperative day 1
|
Apgar scores at 1 and 5 minutes will be recorded.
In addition, the need for neonatal intensive care unit (NICU) admission and any requirement for additional neonatal resuscitation will be documented.
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postoperative day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Burhan Dost, Ondokuz Mayıs University
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
- VLQLBITM1
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