STUDY TO COMPARE TWO LOW DOSE OF BUPIVACAINE HEAVY WITH FIXED DOSE OF FENTANYL IN PREGNANT LADY UNDER GOING CESAREAN SECTION.

â??RANDOMISED CONTROLLED TRIAL TO EVALUATE ANALGESIA AND HEMODYNAMIC CHANGES AFTER ADMINISTRATION OF TWO DOSES OF BUPIVACAINE HEAVY ALONG WITH FIXED DOSE OF INTRATHECAL FENTANYL IN PARTURIANTS UNDERGOING LOWER SEGMENT CAESARIAN SECTION SURGERIESâ??

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/015087

Enrollment

Registered

2018-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pregnant female posted for caesarean section at Tertiary Care Hospital in western India.

Interventions

Intervention1: nil: nil Control Intervention1: compare the analgesia and hemodynamic changes after administration of two different doses of Bupivacaine Heavy along with intrathecally administered fixe

drug is prepared and given to me by other anesthesia resident. 1

Eligibility

Inclusion criteria

Inclusion criteria: • Patients belonging to ASA class I and II with singleton pregnancy with term gestation posted for caesarean section for various indications like cephalo-pelvic disproportion; repeat caesarean section etc, who had no contraindication for spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with co-morbid conditions like anemia, diabetes mellitus, asthma, hypertension, cardiac diseases and other systemic problems . 2. Patients belonging to ASA class III and above. 3. Patients with PIH, eclampsia, multiple gestation, placenta previa, those requiring emergency LSCS. 4. Patient having BMI >30 kg/mÂ². . 5. Patient refusal.

Design outcomes

Primary

Measure	Time frame
1. To compare the time for onset of sensory and motor blockade after giving two different dose of Bupivacaine Heavy and fixed dose of Fentanyl intrathecally. 2. Hemodynamic (NIBP & Heart rate) changes compared to baseline prior to block. 3. Time to first dose of rescue analgesia after surgery or duration of post-operative analgesia. Timepoint: 1. To compare the time for onset of sensory and motor blockade after giving two different dose of Bupivacaine Heavy and fixed dose of Fentanyl intrathecally. 2. Hemodynamic (NIBP & Heart rate) changes compared to baseline prior to block. 3. Time to first dose of rescue analgesia after surgery or duration of post-operative analgesia.	—

Measure

Time frame

1. To compare the time for onset of sensory and motor blockade after giving two different dose of Bupivacaine Heavy and fixed dose of Fentanyl intrathecally. 2. Hemodynamic (NIBP & Heart rate) changes compared to baseline prior to block. 3. Time to first dose of rescue analgesia after surgery or duration of post-operative analgesia. Timepoint: 1. To compare the time for onset of sensory and motor blockade after giving two different dose of Bupivacaine Heavy and fixed dose of Fentanyl intrathecally. 2. Hemodynamic (NIBP & Heart rate) changes compared to baseline prior to block. 3. Time to first dose of rescue analgesia after surgery or duration of post-operative analgesia.

—

Secondary

Measure	Time frame
1. Analgesia at the time of skin incision using pain score 2. Apgar Score of newborn Timepoint: 1. Analgesia at the time of skin incision using pain score 2. Apgar Score of newborn	—

Countries

India

Contacts

Public ContactBRIGADIER DR SUNNY EAPEN

ARMED FORCE MEDICAL COLLEGE

sunny_eapen@yahoo.co.in9878732781

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026