Fundal Pressure, Headache, Intravenous Lidocaine
Conditions
Brief summary
This prospective randomized controlled multicenter study will be conducted to evaluate the effects of pre-emptive IV lidocaine dose on the incidence and severity of intraoperative headache that may occur after the extra-abdominal manual uterine fundal pressure in patients undergoing cesarean section under spinal anesthesia.
Detailed description
This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience. The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP). Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels. The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.
Interventions
DRUGLidocaine IV
IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision after ensuring negative baseline headache.
OTHERSaline 0.9%
IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years * American Society of Anesthesiologists (ASA) Physical Status II * Scheduled for elective cesarean section under spinal anesthesia
Exclusion criteria
* Patients declined to participate in the trial, * Patients with history of any type of headache, mental illness, or cerebrovascular diseases * Previous epidural insertion for painless labor or any other indications; * Patients on opioid or analgesic medications; * Those with pregnancy-induced hypertension or diabetic patients, * Allergy to lidocaine; * Contraindication or failure of spinal anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative headache | Up to the end of surgery. | The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of intraoperative headache | Up to the end of surgery. | The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of headache. |
| The changes in optic nerve sheath diameter | Up to the end of surgery. | Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery. |
| Incidence of shoulder pain | Up to 24 hours after surgery. | The incidence of shoulder pain that may occur intraoperatively and up to 24 hours after surgery will be recorded by asking the patients if they have any pain in their shoulder area. The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of shoulder pain. |
| Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores | Up to 5 minutes after delivery. | Neonatal Apgar scores which include five signs (appearance, pulse, grimace, activity, and respiration) will be recorded at 1 min and 5 minutes after delivery. Each sign has a score of 0, 1, 2 with a total score of 10. Scores more than 6 indicate normal good health. |
| side effects | Intraoperative up to 1 hour after surgery. | Nausea and vomiting, hypotension and bradycardia will be recorded |
| Incidence of postoperative headache | Up to 24 hours after surgery. | The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded. |
Countries
Egypt
Contacts
CONTACTOsama M Rehab, MD
Outcome results
None listed