Sphenopalatine Ganglion Block Versus Conservative Management for Post-Dural Puncture Headache Following Accidental Large-Bore Dural Puncture: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Feasibility: recruitment rate
研究概览
简要总结
This pilot randomised controlled trial compared sphenopalatine ganglion block (SPGB) using intranasal 2% lidocaine versus conservative management (bed rest and aggressive hydration) in patients who developed post-dural puncture headache (PDPH) following accidental dural puncture with 17G Tuohy needles during epidural procedures. The primary outcomes were feasibility metrics (recruitment, retention, and protocol adherence). Secondary outcomes included pain intensity measured by the Numerical Rating Scale (NRS 0-10) at 30 minutes, 12 hours, and 24 hours post-intervention; rescue analgesia requirements; mobilisation time; and adverse events.
详细描述
Post-dural puncture headache is a significant complication of neuraxial anaesthesia, with substantially higher incidence and severity following accidental large-bore needle punctures. Conservative management (bed rest, hydration) lacks robust efficacy evidence, and epidural blood patch implementation is often delayed. The sphenopalatine ganglion block has emerged as a promising minimally invasive alternative, but high-quality randomised trial data are limited.
This single-centre, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Twenty-six patients (ASA I-II, age 18-55 years) who developed PDPH following accidental dural puncture with 17G Tuohy needles during epidural procedures were randomised using a computer-generated sequence to conservative management (n=13) or SPGB (n=13).
Conservative management comprised strict bed rest (supine then prone positioning), bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline 125 mL/hr plus a minimum of 3L oral fluids/24h). SPGB involved bilateral insertion of cotton-tipped applicators saturated with 2 mL of 2% lidocaine at 45° to the hard palate, advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes. Interventions were initiated immediately post-randomisation. The outcome assessor was blinded to group allocation.
The trial was prospectively approved by the institutional ethics and research committee (Reference A2024-1014) and registered with the ISSSTE institutional research registry (RPI #408-2024) prior to enrolment of the first participant. Registration on ClinicalTrials.gov was not completed at the time of study initiation due to institutional policy restrictions in place at that time. This record documents the study retrospectively; the prospective institutional approval and registration are documented under the IRB approval number above.
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
- Single (Outcomes Assessor)
盲法说明
This was a single-blind trial. Blinding of patients and treating clinicians was not feasible given the nature of the interventions. The outcome assessor collecting NRS pain scores was instructed to remain blinded to group allocation and was not involved in treatment delivery.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •ASA physical status I or II
- •Developed post-dural puncture headache following accidental dural puncture with a 17G Tuohy needle during an epidural procedure
- •Enrolled within 24 hours of dural puncture
- •PDPH diagnosed clinically as headache with postural characteristics (worsening upright, relief supine), consistent with ICHD criteria
- •Willing to provide written informed consent
排除标准
- •History of migraine or chronic headache
- •Received prior intervention for PDPH before enrolment
- •Chronic use of anticonvulsants, gabapentinoids, or weak opioids
- •Elimination Criteria:
- •Patient withdrawal of consent at any point during the study
- •Development of side effects requiring further interventional management
研究组 & 干预措施
SPGB
Participants received bilateral sphenopalatine ganglion block using cotton-tipped applicators saturated with 2 mL of 2% lidocaine, inserted at 45° to the hard palate and advanced along the superior border of the middle turbinate to the posterior nasopharyngeal wall, remaining in place for 15-20 minutes before removal.
干预措施: Sphenopalatine ganglion block (Procedure)
CON
Participants received conservative management comprising strict bed rest (supine then prone positioning) with bathroom privileges at bedside only, and aggressive hydration (IV 0.9% saline at 125 mL/hr plus a minimum of 3L oral fluids per 24 hours).
干预措施: Conservative management (Other)
结局指标
主要结局
Feasibility: recruitment rate
时间窗: At study completion (enrolment period)
Proportion of eligible patients who were successfully recruited and randomised to meet the pre-specified pilot sample size target of 26 participants.
Feasibility: retention rate
时间窗: At 24 hours post-intervention (T3)
Proportion of randomised participants who completed all follow-up assessments through 24 hours, expressed as a percentage with 95% confidence interval.
Feasibility: protocol adherence
时间窗: Throughout the 24-hour observation period
Proportion of participants in each group who received their allocated intervention in full accordance with the study protocol, expressed as a percentage with 95% confidence interval.
次要结局
- Pain intensity by Numerical Rating Scale (NRS)(Immediately post-intervention (T0), at 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
- Rescue analgesia requirement(At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
- Time to mobilisation(At 30 minutes (T1), 12 hours (T2), and 24 hours (T3) post-intervention)
- Adverse events(Throughout the 24-hour observation period)
研究者
Mirna Magali Delgado Carlo
MD, Head and Coordinator of Anesthesiology Graduate Program, Principal Investigator
ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"