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Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section

ConditionsIntravenous LidocaineFundal PressureHeadache
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18 years

American Society of Anesthesiologists (ASA) Physical Status II

Scheduled for elective cesarean section under spinal anesthesia

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine IV

    Drug

    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.

  • Saline 0.9%

    Other intervention

    IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.

Treatment groups

680 Participants
are divided into 2 treatment groups
Group A: Lidocaine groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of intraoperative headache

The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.

Time frame
Up to the end of surgery.

Secondary outcomes

1

Severity of intraoperative headache

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.

Time frame
Up to the end of surgery.
2

The changes in optic nerve sheath diameter

Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery.

Time frame
Up to the end of surgery.
3

Incidence of shoulder pain

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.

Time frame
Up to 24 hours after surgery.
4

Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores

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.

Time frame
Up to 5 minutes after delivery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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