Trials / Completed
CompletedNCT02999919
Body Mass Index and Post-dural Puncture Headache
The Relationship Between Body Mass Index and Post-dural Puncture Headache in Pregnant Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 420 (actual)
- Sponsor
- Sakarya University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress, dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery. Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this study investigated the influence of body mass index (BMI) on PDPH in elective caesarean section patients in whom 27G spinal needles were used.
Detailed description
The study included 420 women with American Society of Anesthesiology physical status I-II who underwent elective caesarean section under spinal anesthesia. The patients with a BMI less than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after the procedure, and by phone calls on days 3 and 7.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | spinal anesthesia | 12.5 mg hyperbaric bupivacaine intrathecally following a successful dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space in the sitting position |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2016-12-21
- Last updated
- 2016-12-21
Source: ClinicalTrials.gov record NCT02999919. Inclusion in this directory is not an endorsement.