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The effect of posture and daily fluid intake on dural puncture headache after spinal anesthesia : a factorial randomized controlled, multi-center study

The effect of posture and daily fluid intake on dural puncture headache after spinal anesthesia : a factorial randomized controlled, multi-center study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180510001
Enrollment
560
Registered
2018-05-10
Start date
2018-05-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-dural puncture headache PDPH, pregnancy, women

Interventions

Bed rest for 6 hour with administration of supplementary fluids.,Bed rest for 6 hour without administration of supplementary fluids.,Immediate mobilization with administration of supplementary fluids.
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Sponsors

NoneFaculty of Medicine, Maharaj Nakorn Chiang Mai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: - Patient age between 18 - 45 years old - American Society of Anesthesiologists (ASA) class I - II - Elective orthopedics surgery, general surgery, urological surgery and obstetric gynecological surgery which are able to perform under spinal anesthesia

Exclusion criteria

Exclusion criteria: - Contraindicated to spinal anesthesia: patient refuse, coagulopathy, skin infection at the site of spinal puncture, sepsis, CNS infection - Patients who had medical illness whose cannot tolerate to fluid supplementation such as congestive heart failure or pulmonary edema - Patients who had a history of chronic headache, chronic backache, PDPH, severe nausea or vomiting or backache after anesthesia or surgery - Renal failure or hepatic failure - Patients with neurological abnormalities such as increase intracranial pressure, CNS tumor, hydrocephalus - Patients who had a cognitive impairment or psychological impairment - Obstetric patients with complications such as pre-eclampsia, fetal distress - Emergency surgery - Allergy to local anesthetic drugs - Previous lumbar puncture or spinal anesthesia in the previous 4 weeks - Multiple lumbar punctures (more than 5 attempts) or repeated lumbar puncture - Severe bleeding (blood loss > 20% of blood volume)

Design outcomes

Primary

MeasureTime frame
Incidence of PDPH Every 12 hours for 5 consecutive days Assess the patient’s symptoms,Severity of PDPH Every 12 hours for 5 consecutive days Assess the parient’s symptoms,Characteristics of PDPH Every 12 hours for 5 consecutive days Assess the patient’s symptoms

Secondary

MeasureTime frame
Any types of headache Every 12 hours for 5 consecutive days Assess the patient’s symptoms,Incidence and severity of backache after surgery Every 12 hours for 5 consecutive days Assess the patient’s symptoms,Nausea and vomitting Every 12 hours for 5 consecutive days Assess the patient’s symptoms,Risk factors associated to the occurrence of headache after dural puncture 5 days after surgery Statistical analysis,Adverse event(s) related to study interventions Every 12 hours for 5 consecutive days Record the event(s) during the study

Countries

Thailand

Contacts

Public ContactArtid Samerchua

University hospital

artidsamerchua@gmail.com6653935522

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026