Comparison of haemodynamic parameters following two regimes of fractionated doses of Levobupivacaine in lower segment caesarean section under spinal anaesthesia.

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/08/056548

Lead Sponsor: Department of Anaesthesia,School of Medical Sciences and Research and Sharda Hospital

Brief Summary: Spinal anaesthesia is a commonly practiced anaesthetictechnique in patients undergoingelective or emergency lower segment caesarean sections. It is a safe, costeffective and easy to perform technique which provides a denser block and somore preferred. It also avoids thevarious complications of general anaesthesia like stress response, airwaymanagement, post-operative nausea and vomiting and thereby facilitates earlierresumption of feeding and mobilization. Spinal anaesthesia has a quick onsetand provides satisfactory sensory and motor blockade. Administration of theappropriate choice and dose of local anaesthetic into the subarachnoid space results in rapid onset ofdeep spinal anaesthesia with a greater degree of success .The rapidity of onsetof spinal block is advantageous in cases where delivery of the foetus needs tobe hastened due to compromised fetalstate.1

The required dosage of effective block for LSCS has beenassociated with maternal arterial hypotension of 60-90% with maternal andneonatal morbidity2.The haemodynamic stability andprolonged duration of analgesia were observed by injecting the localanaesthetic drug in divided doses into the subarachnoid space.3-5

Spinal anaesthesia(SA) has rapidonset and is associated with various problems e.g. bradycardia , hypotension .Maternal hypotension may lead to decrease in uteroplacental perfusion which mayresult in fetal acid base imbalance, maternal nausea and vomiting and may be animportant contributory factor for maternal morbidity related to regionalanaesthesia.1 Maternal hypotension andsubsequent consequences are reduced to some extent by various measures likepreloading or coloading of crystalloids or colloids , low dose localanaesthetic, left uterine displacement, prophylactic use of vasopressors etcbut with reduction in incidence and severity of hypotension..

Several factors like height, weight, pregnancy andanatomical changes influence the dose of local anaesthetic drug for its intensity and duration of spinal block.Many physiological and anatomical changes during pregnancy affect spinalanaesthesia. The hormonal and mechanical factors make pregnant women requireless local anaesthetic than non-pregnant women to attain same level of spinalanaesthesia.6

Levobupivacaine is an effective long acting amide localanaesthetic and is an S enantiomer of racemic bupivacaine , since it does notconatin R isomer , cardiotoxicity and neurotoxicity is lesser than bupivacaine.

In this regard, in addition to above mentioned measures,fractionated doses of local anaesthetic for spinal anaesthesia has been used toassess its effect on haemodynamic parameters in caesarean section.

In these studies, a fraction of two-third of calculateddose of local anaesthetic followed by one-third was used for spinal anaesthesia,with the incidence of hypotension during spinal anaesthesia in about 16 %patients as compared to 46% patients who had hypotension with non fractionateddoses (bolus doses).

Extensive search of literature did not show any studycomparing the two fractionated doses (one -thirdfollowed by two-third versus two-third followed by one-third)of localanaesthetic agent for spinal anaesthesia in the patients of caesarean section.

In the present study, haemodynamic parameters will becompared in spinal anaesthesia induced with either of two regimes offractionated doses (one -third followed by two-third versus two-third followedby one-third ) or single bolus dose of Levobupivacaine 0.5% Heavy in patients of caesarean section.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 105

Inclusion Criteria

1.Patients scheduled for LSCS under spinal anaesthesia 2.ASA class II 3.Age 18-35 years 4.Height-140-170cms 5.BMI<30kg/m2 6.Uncomplicated singleton pregnancies 7.Patient having systolic blood pressure between 110-130mm of Hg.

Exclusion Criteria

1.Patient having history of any systemic illness of cardiovascular system, respiratory system, endocrine, renal or hepatic disorders.
2.Fetal distress (as diagnosed by obstetrician) 3.BMI >30% kg / m2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the number of patients requiring mephentermine to maintain systolic blood pressure Â±20% of baseline value in three groups. (Two groups of fractionated doses & one group of bolus dose).	Perioperatively till 2 hours in same setting

Secondary Outcome Measures

Name	Time	Method
To compare total requirement of mephentermine among three groups	To compare haemodynamic parameters HR SBP DBP MAP

Trial Locations

Locations (1): School of Medical Sciences and Research and Sharda Hospital
🇮🇳
Nagar, UTTAR PRADESH, India
School of Medical Sciences and Research and Sharda Hospital
🇮🇳Nagar, UTTAR PRADESH, India
Dr Krishna Lakhmani
Principal investigator
9839963805
krishnalakhmani21@gmail.com