Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section (LID-HEAD)
Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled Trial
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Osama M Rehab, MD
- 전화번호: +201095210806
- 이메일: osamarehab@med.tanta.edu.eg
연구 장소
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Gharbia Governorate
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Tanta, Gharbia Governorate, 이집트, 31527
- 모병
- Tanta University Hospitals
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연락하다:
- Osama M Rehab, MD
- 전화번호: +201095210806
- 이메일: osamarehab@med.tanta.edu.eg
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Lidocaine group
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
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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.
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위약 비교기: Control group
IV 10 ml isotonic saline over the same period
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IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of intraoperative headache
기간: Up to the end of surgery.
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The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
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Up to the end of surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Severity of intraoperative headache
기간: Up to the end of surgery.
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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.
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Up to the end of surgery.
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The changes in optic nerve sheath diameter
기간: Up to the end of surgery.
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Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery.
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Up to the end of surgery.
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Incidence of shoulder pain
기간: Up to 24 hours after surgery.
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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.
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Up to 24 hours after surgery.
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Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores
기간: Up to 5 minutes after delivery.
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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.
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Up to 5 minutes after delivery.
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side effects
기간: Intraoperative up to 1 hour after surgery.
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Nausea and vomiting, hypotension and bradycardia will be recorded
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Intraoperative up to 1 hour after surgery.
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Incidence of postoperative headache
기간: Up to 24 hours after surgery.
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The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded.
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Up to 24 hours after surgery.
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 36265PR75/5/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
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