To compare the effect of consecutive versus premixed administration of hyperbaric bupivacaine and fentanyl in neuraxial anaesthesia for caesarean section
- Conditions
- Encounter for delivery,
- Registration Number
- CTRI/2021/10/037039
- Lead Sponsor
- Department of Anaesthesiology
- Brief Summary
**Introduction:** Spinal anaesthesia is the preferred technique for caesarean section being easy to perform, cost effective, having higher efficiency, causing lesser neonatal depression and decreased risk of aspiration of gastric contents. Hyperbaric bupivacaine is commonly used local anaesthetic for spinal anaesthesia in caesarean section .Local anaesthetics in neuraxial anaesthesia block motor and sensory system. They also block sympathetic nervous system which causes unwanted physiological alterations. Certain adjuvants like fentanyl are used to minimize the side effects of local anaesthetics by bringing down their volume. Addition of fentanyl to hyperbaric bupivacaine may alter the density of the mixture and affect the spread of hyperbaric bupivacaine. If both drugs are injected separately in different syringes, it may minimize the effect of changes in densities and pH of both drugs.
**Aims and Objectives:**
- To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
- To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section.
**Materials and Methods:**Study will be conducted in the Department of Anaesthesiology at Guru Gobind Singh Medical College and Hospital, Faridkot. **Inclusion criteria:** (1) Patients belonging to American Society of Anaesthesiologist Grade I and II. (2) Parturients aged 18-35 years undergoing caesarean section. **Exclusion criteria:**(1) Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation. (2) BMI greater than 35 or less than 22 Kg/m2. (3) Height less than 150 cm. and greater than 170 cm. (4) Gestational age less than 36 weeks. (5) Major systemic diseases (cardiac, renal, liver). (6) Having allergy to drugs used in the study. (7) Patients having neuropathies. (8) Having contraindications for spinal anaesthesia.
**Methodology:**A total of 120 patients divided into 3 groups (40 each) i.e. **Group A:** Patients receiving 2.0 ml of 0.5% hyperbaric bupivacaine followed by 25 mcg of fentanyl through separate 3 ml syringes, **Group B:** Patients receiving 25 mcg of fentanyl followed by 2.0 ml of 0.5% hyperbaric bupivacaine through separate 3 ml syringes, **Group C:** Patients receiving 2.0 ml of 0.5 % hyperbaric bupivacaine + 25 mcg of fentanyl premixed in a 3 ml syringe.
**Parameters assessed:**Onset of sensory block in 3 groups, Onset of motor block in 3 groups, Time of regression of sensory block, Time of regression of motor block, Vital parameters of patient like pulse rate, blood pressure, SPO2, frequency of hypotension, need for vasopressors, Requirement of rescue analgesia, Neonatal outcome in the form of Apgar score, Patient satisfaction score.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 120
•Patients belonging to American Society of Anesthesiologist Grade I and II •Parturients aged 18-35 years undergoing caesarean section.
•Parturients with complicated pregnancy as preeclampsia, pregnancy induced hypertension, gestational diabetes, abnormal placenta (placenta praevia), multiple gestation •BMI greater than 35 or less than 22 Kg/m2 •Height less than 150 cm and greater than 170 cm •Gestational age less than 36 weeks •Major systemic diseases (cardiac, renal, liver) •Having allergy to drugs used in the study •Patients having neuropathies •Having contraindications for spinal anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To study the effect of consecutive administration of hyperbaric bupivacaine followed by fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section. Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min. •To study the effect of consecutive administration of fentanyl followed by hyperbaric bupivacaine on the time of onset of sensory block in neuraxial anaesthesia for caesarean section. Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min. •To study the effect of premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section. Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min. •To compare the effect of consecutive with premixed administration of hyperbaric bupivacaine and fentanyl on the time of onset of sensory block in neuraxial anaesthesia for caesarean section. Time of onset of sensory block will be assessed. Segmental sensory level of anaesthesia will be assessed by pts response to pinprick every 2 min. till 20 min.
- Secondary Outcome Measures
Name Time Method •Time of onset of motor block •Time of regression of sensory block.
Trial Locations
- Locations (1)
Guru Gobind Singh Medical College And Hospital, Faridkot
🇮🇳Faridkot, PUNJAB, India
Guru Gobind Singh Medical College And Hospital, Faridkot🇮🇳Faridkot, PUNJAB, IndiaDr Seema JindalPrincipal investigator9646050485jindalseema77@gmail.com