Efficacy of Ultrasound-Guided Erector Spinae Block for Postoperative Pain Management in Nephrectomy
Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Postoperative Pain Management in Nephrectomy: A Randomized Controlled Trial
This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.
Patients will be randomly assigned to one of two groups:
Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.
The main goals are to determine:
How much pain relief each method provides, measured using a visual analog scale (VAS).
The total amount of opioids required during the first 24 hours post-surgery.
Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.
This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.
This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.
The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:
Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.
Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.
The primary outcome of the trial is to measure the first postoperative opioid requirement, utilizing the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes include the total opioid consumption in the first 24 hours, the intensity of postoperative pain at various time points, and the hemodynamic responses (heart rate, blood pressure). Additionally, peak expiratory flow rate (PEFR) will be monitored to assess respiratory function as part of the recovery process.
By evaluating these outcomes, the study aims to provide insights into whether ESP block can serve as a safer, effective alternative to traditional analgesia, improving postoperative pain management and reducing the risks associated with opioid use. The results may guide clinical practice in nephrectomy pain management, offering a potential improvement in patient recovery times and satisfaction.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kazi Mahzabin Arin, MD
- 전화번호: +8801754057689
- 이메일: kazimahzabinarin@bsmmu.edu.bd
연구 연락처 백업
- 이름: AKM Akhtaruzzaman, MD
- 전화번호: +8801819220195
- 이메일: akm.akhtaruzzaman@bmu.ac.bd
연구 장소
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Dhaka, 방글라데시, 1000
- 모병
- Bangladesh Medical University
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연락하다:
- Kazi Mahzabin Arin, MD
- 전화번호: +8801754057689
- 이메일: kazimahzabinarin@bsmmu.edu.bd
-
연락하다:
- AKM Mahzabin Akhtaruzzaman, MD
- 전화번호: +8801819220195
- 이메일: akm.akhtaruzzaman@bmu.ac.bd
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult patients aged 18 to 64 years
- Scheduled for open nephrectomy (radical or partial) under general anesthesia
- ASA physical status I-II (American Society of Anesthesiologists classification)
Exclusion Criteria:
- Allergy to local anesthetics.
- Local infection or inflammation at the site of the Block placement.
- Presence of anatomical deformities in the spine
- Coagulopathy or any bleeding disorder.
- Pregnancy or breastfeeding women.
- History of severe chronic pain syndrome
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: Control Group: Conventional Pain Management
This group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care
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실험적: Intervention Group: Ultrasound-Guided Erector Spinae Plane Block
Patients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia.
The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption.
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The Ultrasound-Guided Erector Spinae Plane (ESP) Block is a regional anesthesia technique used to provide postoperative pain relief.
In this study, the intervention involves the administration of a local anesthetic (0.25% bupivacaine) into the fascial plane between the erector spinae muscle and the transverse process of the vertebra using ultrasound guidance.
The procedure is performed immediately before the induction of general anesthesia in patients undergoing open nephrectomy.
The goal of the ESP block is to reduce postoperative pain, minimize opioid consumption, and improve recovery outcomes while maintaining hemodynamic stability.
This intervention is compared to conventional pain management methods, which primarily rely on systemic opioids and other standard analgesics.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analogue Scale (VAS) for pain
기간: VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.
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VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain. A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control. |
VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Opioid Consumption
기간: Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
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Total opioid consumption will be tracked and recorded for each group during the first 24 hours post-surgery.
The total amount of opioids used (in milligrams) will serve as an indicator of pain control effectiveness.
A reduction in opioid consumption in the ESP block group, compared to the control group, would suggest that the ESP block is effective in reducing the need for opioids, thereby minimizing opioid-related side effects.
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Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.
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Peak Expiratory Flow Rate (PEFR)
기간: PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
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PEFR will be measured preoperatively and at multiple points postoperatively (1, 3, 6, and 24 hours) to assess respiratory function.
This is particularly important in nephrectomy patients, as effective pain management helps promote better respiratory outcomes and reduce the risk of atelectasis or other complications.
A higher PEFR value suggests better lung function and recovery.
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PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.
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Heart Rate (HR) Monitoring
기간: Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Heart rate (HR) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours).
This will help assess whether the ESP block maintains hemodynamic stability without causing significant fluctuations, such as tachycardia (increased heart rate), compared to conventional analgesia methods.
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Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Systolic Blood Pressure (SBP) Monitoring in mmHg
기간: Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Systolic blood pressure (SBP) will be recorded preoperatively and at regular intervals (0, 1, 3, 6, 12, and 24 hours) postoperatively.
The aim is to evaluate whether the ESP block offers better hemodynamic control by preventing significant blood pressure fluctuations compared to conventional analgesia methods.
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Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Diastolic Blood Pressure (DBP) Monitoring in mmHg
기간: Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Diastolic blood pressure (DBP) will be measured preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours).
Monitoring DBP helps assess the stability of the cardiovascular system and ensure that the ESP block does not lead to significant hypotension or other adverse effects on circulation.
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Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Mean Arterial Pressure (MAP) Monitoring in mmHg
기간: Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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Mean arterial pressure (MAP) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours).
MAP is a key indicator of perfusion pressure, ensuring adequate blood flow to organs.
This outcome will evaluate whether the ESP block maintains stable MAP levels compared to conventional analgesic methods.
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Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: AKM Akhtaruzzaman, MD, Bangladesh Medical University
간행물 및 유용한 링크
일반 간행물
- Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
- Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.
- Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr.
- Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848.
- Yang JH, Sun Y, Yang YR, Qi LN, Li WY, Qin XZ. The Analgesic Mechanism and Recent Clinical Application of Erector Spinae Plane Block: A Narrative Review. J Pain Res. 2024 Sep 17;17:3047-3062. doi: 10.2147/JPR.S468560. eCollection 2024.
- Yetneberk T, Chekol B, Teshome D. The efficacy of TAP block versus ilioinguinal block for post-cesarean section pain management: A systematic review and meta-analysis. Heliyon. 2021 Aug 13;7(8):e07774. doi: 10.1016/j.heliyon.2021.e07774. eCollection 2021 Aug.
- Unal S, Baskan S, Guven Aytac B, Aytac I, Balci M. Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? Cureus. 2022 Feb 24;14(2):e22554. doi: 10.7759/cureus.22554. eCollection 2022 Feb.
- Ni Y, Yang X. A Systematic Review and Meta-Analysis of Comparison of Outcomes of Robot-Assisted versus Open Partial Nephrectomy in Clinical T1 Renal Cell Carcinoma Patients. Urol Int. 2022;106(8):757-767. doi: 10.1159/000521881. Epub 2022 Feb 22.
- Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
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처음 게시됨 (실제)
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연구 기록 업데이트
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마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- BSMMU/2025/2025
개별 참가자 데이터(IPD) 계획
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연구 프로토콜
정보 식별자: pain.medicine@bsmmu.edu.bd
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