Postdural Puncture Headache, Postoperative Nausea and Vomiting, Obstetric Anesthesia Problems
Conditions
Keywords
Ondansetron, Dexamethasone, Postdural Puncture Headache, Nausea, Vomiting
Brief summary
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.
Detailed description
This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia. A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation. All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in: Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline), Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL), Group C (Control group) received 5 mL of 0.9% normal saline IV. Study drugs were administered 5 minutes prior to the intrathecal injection. Blinding was maintained for patients, anesthesiologists, and outcome assessors. PDPH was assessed for 7 days postoperatively. A standardized questionnaire and the Corbey scale were used to evaluate headache onset, severity, duration, and need for analgesics. Nausea and vomiting were assessed intraoperatively and postoperatively (up to 48 hours). Standard antiemetic rescue therapy was available as needed. The protocol adhered to CONSORT guidelines and was approved by the Minia University Faculty of Medicine Research Ethics Committee. All participants provided written informed consent prior to enrollment. This trial investigates whether prophylactic ondansetron or dexamethasone, individually, can significantly reduce PDPH and PONV compared to placebo. The results are expected to inform perioperative management and enhance maternal outcomes in cesarean section under spinal anesthesia.
Interventions
Dexamethasone 8 mg IV Administered 5 minutes before spinal anesthesia
5ml normal saline Administered 5 minutes before spinal anesthesia
Ondansetron 8 mg IV Administered 5 minutes before spinal anesthesia
Sponsors
Study design
Masking description
This was a double-blind study. Both the patients and the care providers (anesthesiologists) were blinded to the group assignments. Study medications were prepared in identical 5 mL syringes labeled A, B, or C by an independent supervisor who was not involved in patient care, drug administration, or data collection. Neither the participants nor the medical staff administering the anesthesia or assessing outcomes were aware of the group allocations
Intervention model description
This study is a parallel assignment model in which 150 parturients undergoing elective cesarean section under spinal anesthesia were randomized into three groups in a 1:1:1 ratio to receive either intravenous ondansetron, dexamethasone, or placebo. Each participant was assigned to one intervention group and remained in that group for the duration of the study.
Eligibility
Inclusion criteria
* Female patients aged 18 to 45 years * Body Mass Index (BMI) between 23-27 kg/m² * American Society of Anesthesiologists (ASA) physical status I or II * Scheduled for elective cesarean section under spinal anesthesia
Exclusion criteria
* Refusal to participate * Conversion to general anesthesia due to failed spinal block * Known hypersensitivity to ondansetron or dexamethasone * Contraindications to study medications, including: * Diabetes mellitus * Active infection * Prolonged QT interval * History of tobacco or drug use * Coagulopathy or localized infection at the spinal injection site * High-risk pregnancy (e.g., preeclampsia, placenta previa) * History of chronic headache or migraine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postdural Puncture Headache (PDPH) | Up to 14 days postoperatively | The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of PDPH | Up to 14 days postoperatively | Severity of PDPH will be assessed using the Corbey Headache Severity Scale, which categorizes headache as: Mild (no limitation of daily activity), Moderate (some limitation of activity but no bed rest required), and Severe (requires bed rest). Scale: Mild to Severe - higher levels indicate worse outcome |
| Duration of PDPH | Up to 14 days postoperatively | Duration (in days) from onset to resolution of PDPH symptoms in affected participants. |
| Incidence of Nausea and Vomiting (N/V) | Intraoperatively and up to 4 days postoperatively | Incidence of intraoperative and postoperative nausea and vomiting, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = nausea and vomiting, 3 = repeated vomiting). |
| Neonatal Outcome (Apgar Score at 1 and 5 minutes) | At 1 minute and 5 minutes after birth | Neonatal wellbeing will be assessed using the Apgar Score, a standardized clinical scale that evaluates Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration. Scale Description: Minimum Score: 0 (worst outcome) Maximum Score: 10 (best outcome) Higher scores reflect better neonatal condition |
Countries
Egypt