Leg Wrapping and Norepinephrine for Prevention of Post Spinal Hypotension in C.S
NCT Number: NCT06496061
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Post Spinal Hypotension
Interventions: DRUG: Norepinephrine|PROCEDURE: Leg wrapping
Sponsor: Fayoum University
Sex: FEMALE
Age: ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-01-01
Locations: Fayoum University hospital, Madīnat Al Fayyūm, Faiyum Governorate, 63514, Egypt

Summary:
Maternal hypotension after subarachnoid block is considered one of the most common complications that occurs during cesarean delivery, with an incidence of up to 70-80%. Maternal hypotension has adverse effects on both the mother and the fetus such as maternal nausea, vomiting, dizziness, cardiovascular collapse, fetal acidosis, and low Apgar scores).Hence, the prevention of spinal anesthesia-induced hypotension became a topic of great interest for clinicians as well as in literature aiming to improve maternal and neonatal safety. The main etiologies of spinal anesthesia-induced hypotension are aortocaval compression caused by a gravid uterus before delivery of the baby, blood pooling in the lower limbs, and loss of vascular tone as a result of sympatholysis during spinal anesthesia. Based on those mechanisms, Various prophylactic methods have been suggested and tried, including intravenous fluid loading, vasopressors, and physical interventions such as left lateral tilt, leg elevation, and wrapping with crepe bandage (CB). Fluid co-loading with Crystalloids is considered superior to crystalloid preloading and equivalent to colloid preloading. Despite that fluid loading decreased the incidence of hypotension, more interest was directed to vasopressors such as ephedrine, phenylephrine, and norepinephrine. Different regimens have been investigated including continuous infusion or boluses of those vasopressors with promising results reaching lower incidences of hypotension after intrathecal anesthesia but those incidences are still considerable and efforts are made to reach the optimum doses and least hypotension incidences.

Lower limb wrapping with crepe bandages is a simple, non-invasive, nonpharmacological, cost-effective tool that stops blood from pooling in the lower limbs and escaping the central circulation. This method was found to decrease intrathecal-induced hypotension in cesarean delivery to incidences down to 10% in some studies.

We hypothesize that the combination of a pharmacological agent as norepinephrine infusion and a nonpharmacological method as leg wrapping with crepe bandages may help in the prevention of spinal-induced hypotension during Cesarean delivery more than using only one of them.

Primary Outcome Measures: the incidence of post-spinal hypotension, decrease in SBP by more than 20% of the baseline reading during the period from intrathecal injection to delivery, From spinal anesthesia to delivery up to 60 minutes
Secondary Outcome Measures: incidence of sever post-spinal hypotension, a decrease in SBP by more than 40% of the baseline reading, From spinal anesthesia to delivery up to 60 minutes|total dose of ephedrine, Amount of ephedrine had been used, From spinal anesthesia to end of surgery up to 60 minutes|incidence of hypertension, an increase in SBP by more than 20% of the baseline, From spinal anesthesia to delivery up to 60 minutes|incidence of post-delivery hypotension, a decrease in SBP by more than 20% of baseline, after delivery to the end of the surgery up to 60 minutes|incidence of bradycardia, heart rate less than 55 beats per minute, From spinal anesthesia to end of surgery up to 60 minutes|Incidence of tachycardia, Heart rate increased by more than 30% of baseline not related to hypotension or ephedrine use, From spinal anesthesia to end of surgery up to 60 minutes|Incidence of nausea and vomiting, Nausea and vomiting occuring intraoperative, From spinal anesthesia to end of surgery up to 60 minutes|Umbilical Artery blood gases, Measuring pH, pco2,po2 , Hco3 and lactate for umbilical artery blood sample, From delivery up to 5 minutes|Apgar score, Measuring Apgar score for neonate, From delivery up to 5 minutes