Leg Wrapping and Norepinephrine for Prevention of Post Spinal Hypotension in C.S

NCT06496061 | Completed Phase 4

• 1 other identifier: M728
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Spinal Hypotension

Keywords

Post spinal hypotension; Leg wrapping; Prophylactic norepinephrine infusion; Cesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• incidence of sever post-spinal hypotension

  From spinal anesthesia to delivery up to 60 minutes

• total dose of ephedrine

  From spinal anesthesia to end of surgery up to 60 minutes

• incidence of hypertension

  From spinal anesthesia to delivery up to 60 minutes

• incidence of post-delivery hypotension

  after delivery to the end of the surgery up to 60 minutes

• incidence of bradycardia

  From spinal anesthesia to end of surgery up to 60 minutes

Study Arms (2)

Leg wrapping and norepinephrine infusion

EXPERIMENTAL

Leg wrapping and norepinephrine infusion. using a crepe bandage (CB) to wrap both legs of the patient from the ankle up to mid-thigh. This CB will be applied tightly enough that the patient feels the tightness but is still comfortable with intact capillary pulsation in the toes and applying norepinephrine infusion 0.5 mg norepinephrine added to 50 ml Normal Saline and set it to run with 0.05 mg/kg/min.

Drug: Norepinephrine; Procedure: Leg wrapping

Norepinephrine infusion

ACTIVE COMPARATOR

Norepinephrine infusion . applying norepinephrine infusion 0.5 mg norepinephrine added to 50 ml Normal Saline and set it to run with 0.05 mg/kg/min.

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

Norepinephrine infusion with 0.05 mg/kg/h

Also known as: Noradrenaline infusion

Leg wrapping and norepinephrine infusion; Norepinephrine infusion

Leg wrapping PROCEDURE

Elastic leg wrapping

Also known as: Elastic stockings

Leg wrapping and norepinephrine infusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged more than 18 years old with a single full-term fetus, scheduled for elective cesarean delivery

You may not qualify if:

• parturients with cardiac Co-morbidities, baseline hypotension with Systolic Blood pressure (SBP) less than 100 mmHg, hypertensive disorders of pregnancy, peripartum bleeding (preoperative placenta Previa or placental abruption), and Body mass index of more than 40 kg/m2, will be excluded. Parturients with Failed intrathecal anesthesia or intraoperative bleeding of more than 500 ml of blood

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (11)

• Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8.

  PMID: 28625306 BACKGROUND

• Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.

  PMID: 27720613 BACKGROUND

• Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.

  PMID: 31741565 BACKGROUND

• Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.

  PMID: 31531852 BACKGROUND

• Tawfik MM, Hayes SM, Jacoub FY, Badran BA, Gohar FM, Shabana AM, Abdelkhalek M, Emara MM. Comparison between colloid preload and crystalloid co-load in cesarean section under spinal anesthesia: a randomized controlled trial. Int J Obstet Anesth. 2014 Nov;23(4):317-23. doi: 10.1016/j.ijoa.2014.06.006. Epub 2014 Jun 30.

  PMID: 25281437 BACKGROUND

• Oh AY, Hwang JW, Song IA, Kim MH, Ryu JH, Park HP, Jeon YT, Do SH. Influence of the timing of administration of crystalloid on maternal hypotension during spinal anesthesia for cesarean delivery: preload versus coload. BMC Anesthesiol. 2014 May 16;14:36. doi: 10.1186/1471-2253-14-36. eCollection 2014.

  PMID: 24920942 BACKGROUND

• Butwick AJ, Columb MO, Carvalho B. Preventing spinal hypotension during Caesarean delivery: what is the latest? Br J Anaesth. 2015 Feb;114(2):183-6. doi: 10.1093/bja/aeu267. Epub 2014 Jul 30. No abstract available.

  PMID: 25080429 BACKGROUND

• Biricik E, Unlugenc H. Vasopressors for the Treatment and Prophylaxis of Spinal Induced Hypotension during Caesarean Section. Turk J Anaesthesiol Reanim. 2021 Feb;49(1):3-10. doi: 10.5152/TJAR.2020.70. Epub 2020 May 5.

  PMID: 33718899 BACKGROUND

• Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.

  PMID: 30935897 BACKGROUND

• Prajith KR, Mishra G, Ravishankar M, Hemanth Kumar VR. Hemodynamic changes under spinal anesthesia after elastic wrapping or pneumatic compression of lower limbs in elective cesarean section: A randomized control trial. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):244-250. doi: 10.4103/joacp.JOACP_72_18. Epub 2020 Jun 15.

  PMID: 33013042 BACKGROUND

• Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.

  PMID: 30335625 BACKGROUND

MeSH Terms

Interventions

Norepinephrine; Stockings, Compression

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Mohamed A Hamed, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)