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Magnesium Sulphate Versus Dexamethasone With TAP Block for Post-Cesarean Analgesia

2026年8月14日 更新者:Maleeha Rahman、Khyber Teaching Hospital

Effectiveness of Intravenous Single-Dose Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Ultrasound-Guided Transversus Abdominis Plane Block for Control of Post-Cesarean Analgesia

This randomized, double-blind, controlled clinical trial will compare the effectiveness of a single intravenous dose of magnesium sulphate versus dexamethasone as an adjuvant to ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management after elective cesarean section. Eighty women undergoing elective lower-segment cesarean section under spinal anesthesia will be randomly allocated into two groups of 40 participants each. Group M will receive intravenous magnesium sulphate 50 mg/kg diluted in 100 mL normal saline, while Group D will receive intravenous dexamethasone 8 mg diluted in 100 mL normal saline. The study will assess postoperative pain using the Visual Analog Scale at 2, 4, 8, 12, and 24 hours after surgery, as well as duration of analgesia, rescue analgesic requirement, total tramadol consumption, and adverse effects. The study aims to determine whether either intravenous adjuvant provides more effective and prolonged postoperative analgesia when used with ultrasound-guided TAP block after cesarean section.

研究概览

详细说明

Post-cesarean pain can affect maternal comfort, mobility, breastfeeding and postoperative recovery. Effective postoperative analgesia is therefore an important component of care following cesarean section. Ultrasound-guided transversus abdominis plane (TAP) block is used as part of multimodal analgesia to provide abdominal wall somatic analgesia and may reduce the requirement for systemic opioid analgesics.

This study will evaluate whether the addition of a single intravenous dose of magnesium sulphate or dexamethasone provides better postoperative analgesia when used as an adjunct to ultrasound-guided TAP block in women undergoing elective cesarean section.

The study will be conducted as a randomized, double-blind, controlled clinical trial in the Department of Anesthesia, Khyber Teaching Hospital, Peshawar. A total of 80 women will be included, with 40 participants allocated to the magnesium sulphate group (Group M) and 40 participants allocated to the dexamethasone group (Group D).

Eligible participants will be women aged 18-40 years undergoing elective lower-segment cesarean section under spinal anesthesia, with ASA physical status I or II, singleton full-term pregnancy of at least 37 weeks, and willingness to provide written informed consent.

Participants with known allergy or contraindication to magnesium sulphate, dexamethasone or local anesthetics; chronic pain disorders or regular analgesic/opioid use; neurological, renal, hepatic or cardiovascular disease; pregnancy complications such as pre-eclampsia, eclampsia or placenta previa; conversion to general anesthesia; inadequate spinal anesthesia or failed TAP block; or refusal to participate will be excluded.

Following enrollment and informed consent, participants will be randomly allocated using a computer-generated randomization list. Group M will receive a single intravenous dose of magnesium sulphate 50 mg/kg diluted in 100 mL normal saline 15 minutes before the TAP block. Group D will receive a single intravenous dose of dexamethasone 8 mg diluted in 100 mL normal saline 15 minutes before the TAP block.

All participants will receive spinal anesthesia at the L3-L4 interspace using a 25-G spinal needle and 0.5% hyperbaric bupivacaine at a dose of 10-12 mg under aseptic conditions.

Following cesarean section and stabilization in the recovery area, all participants will receive a bilateral ultrasound-guided TAP block using 20 mL of 0.25% bupivacaine on each side. The block will be performed by a skilled anesthesiologist using a high-frequency linear ultrasound probe.

Patients will be monitored during the perioperative period for heart rate, blood pressure, respiratory rate and oxygen saturation. Postoperative pain will be assessed using the Visual Analog Scale, with 0 representing no pain and 10 representing the worst imaginable pain. Pain will be assessed at 2, 4, 8, 12 and 24 hours after surgery, both at rest and on movement.

The duration of analgesia will be assessed as the time from administration of the TAP block until the patient's first request for rescue analgesia. Rescue analgesic requirement will be assessed by recording the number of rescue analgesic doses and total tramadol consumption during the first 24 postoperative hours. Each rescue dose of tramadol will be recorded as 50 mg intravenously according to the study protocol.

Adverse effects including nausea, vomiting, dizziness, sedation and allergic reactions will also be recorded. Patient satisfaction with postoperative pain control may also be assessed.

Data collection will be performed by qualified anesthesiology residents who will remain blinded to group allocation. The primary investigator will review completed data collection forms for accuracy and completeness.

The collected data will be entered and analyzed using SPSS version 26.0. Quantitative variables including age, weight, duration of analgesia and total tramadol consumption will be summarized using mean and standard deviation where appropriate. The Shapiro-Wilk test will be used to assess normality. The independent-samples t-test will be used for normally distributed continuous variables, while the Mann-Whitney U test will be used for non-normally distributed variables. Categorical variables, including adverse effects, will be presented as frequencies and percentages and compared using the Chi-square test or Fisher's exact test as appropriate. A p-value of less than 0.05 will be considered statistically significant.

The study will compare the postoperative analgesic effectiveness of intravenous magnesium sulphate and dexamethasone when used as adjuvants to ultrasound-guided TAP block. The outcomes will provide information regarding postoperative pain scores, duration of analgesia, rescue analgesic requirement, total tramadol consumption and adverse effects in women undergoing elective cesarean section.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Women aged 18-40 years.
  • Undergoing elective lower-segment cesarean section under spinal anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Singleton, full-term pregnancy with gestational age of at least 37 weeks.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Known allergy or contraindication to magnesium sulphate, dexamethasone, or local anesthetics.
  • History of chronic pain disorders or regular use of analgesics or opioids.
  • Neurological, renal, hepatic, or cardiovascular disease.
  • Pregnancy complications such as pre-eclampsia, eclampsia, or placenta previa.
  • Intraoperative conversion to general anesthesia.
  • Inadequate spinal block or failed TAP block.
  • Refusal to participate in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Magnesium Sulphate Group
Participants in this group will receive a single intravenous dose of magnesium sulphate 50 mg/kg diluted in 100 mL normal saline, administered 15 minutes before the ultrasound-guided TAP block. Following cesarean section, participants will receive a bilateral ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine on each side.
Magnesium sulphate 50 mg/kg diluted in 100 mL normal saline, administered as a single intravenous dose 15 minutes before the ultrasound-guided TAP block.
有源比较器:Dexamethasone Group
Participants in this group will receive a single intravenous dose of dexamethasone 8 mg diluted in 100 mL normal saline, administered 15 minutes before the ultrasound-guided TAP block. Following cesarean section, participants will receive a bilateral ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine on each side.
Dexamethasone 8 mg diluted in 100 mL normal saline, administered as a single intravenous dose 15 minutes before the ultrasound-guided TAP block.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Duration of analgesia
大体时间:From completion of the TAP block until the first request for rescue analgesia, assessed during the first 24 hours after cesarean section.
Time from administration of the ultrasound-guided TAP block until the participant's first request for rescue analgesia, measured in minutes.
From completion of the TAP block until the first request for rescue analgesia, assessed during the first 24 hours after cesarean section.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年2月28日

研究完成 (估计的)

2027年2月28日

研究注册日期

首次提交

2026年8月14日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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