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临床试验/NCT07434232
NCT07434232尚未招募不适用

Efficacy of Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy: A Prospective, Randomized Controlled Clinical Trial

South Egypt Cancer Institute0 个研究点目标入组 100 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
intravenous opioid consumption

研究概览

简要总结

Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.

Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.

详细描述

Modified radical mastectomy, a common surgical intervention for breast cancer therapy, and is often associated with extensive postoperative pain. Effective regional anesthesia techniques are important modalities to manage this pain and reduce total opioid consumption in the early postoperative phase. A few interfacial nerve block methods (for example, pectoral nerve blocks I and II and erector spinae plane block) are also utilized in some other procedures to reduce the postoperative pain. However, these methods require particular patient positioning.

A new, minimally-invasive technique called pecto-intercostal fascial plane block (PIFB) was firstly used by De la Torre in patients who had undergone breast surgery. The Pecto-Intercostal Fascial Block (PIFB) and the Serratus Anterior Plane Block (SAPB) have appeared as promising techniques for providing pain relief in breast surgeries. PIFB targets the anterior cutaneous branches of the intercostal nerves, while SAPB focuses on the lateral cutaneous branches, each offering distinct anatomical coverage. Some specific benefits have been reported when using PIFB such as less invasiveness, proximity to the incision line, and postoperative administration with no specific patient positioning.

Recent studies have examined the efficacy of adding adjuvants to local anesthetics. Magnesium sulfate, known for its NMDA receptor antagonism and calcium channel blocking properties, has been investigated for its potency to prolong pain relief and improve analgesic control when used as an adjuvant in peripheral blocks. Evaluating the efficacy of magnesium sulfate in these fascial plane blocks may lead to the establishment of an improved standard of care in postoperative pain management.

While both PIFB and SAPB are considered safe and relatively easy to perform using ultrasound, comparative data regarding their efficacy, especially with magnesium sulfate as an adjuvant, remains limited. The outcomes of this study may help define a more effective and standardized analgesic approach for patients undergoing modified radical mastectomy. Furthermore, minimizing systemic opioid requirements is especially gaining interest considering current efforts to reduce opioid-related side effects and dependence in surgical patients.

Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

n online randomization program (http://www.randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner:Patients and outcome assessors will be blinded to the study groups.

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.
  • ASA, I-III and NYHA, I-II.
  • Written informed consent.

排除标准

  • ASA physical status >III and NYHA >II,
  • body mass index >40 kg/m2,
  • pregnant women,
  • Patients with organ failure or coagulation disorders.
  • Allergy to local anesthetics or magnesium sulfate
  • Contraindications as local infection
  • History of chronic pain or opioid use .
  • Unwilling to participate in the study

研究组 & 干预措施

(Control group):

Sham Comparator

patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block).

干预措施: combined Pecto-Intercostal- Serratus anterior fascial planes Block (Procedure)

(Magnesium group).:

Active Comparator

where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))

干预措施: combined Pecto-Intercostal- Serratus anterior fascial planes Block (Procedure)

结局指标

主要结局

intravenous opioid consumption

时间窗: 24 hours postoperatively

total intravenous opioid consumption during the first 24 hours

次要结局

  • pain intensity postoperatively at rest and during pain-provoking movements(24 hours postoperatively)
  • First request of analgesia.(24 hours postoperatively)

研究者

发起方
South Egypt Cancer Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Farghaly Abd El hamid Ahmed

lecturer of anesthesia

South Egypt Cancer Institute

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