Comparison of 2 drugs on shivering and pain in women undergoing caesarean delivery when given as an adjuvant in spinal anesthesia

Comparison of anti-shivering effect and postoperative analgesia between intrathecal fentanyl and morphine as adjuvant to hyperbaric bupivacaine for spinal anesthesia among pregnant women undergoing elective caesarean delivery - Nil

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068651

Enrollment

105

Registered

2024-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Spinal anesthesia: Spinal anesthesia is the most common type of anesthesia given to caesarean delivery where drug is injected in the subarachnoid space, it’s a routine procedure for cae

Eligibility

Inclusion criteria

Inclusion criteria: A. Pregnant women undergoing elective caesarean section who are aged 18-40 yrs. B. American Society of Anesthesiologists physical status I or II with body mass index less than 40 C. With gestation age more than 36 weeks. D. With singleton pregnancy E. With indications for elective caesarean section being maternal request, breech presentation and other malpresentations, fetal compromise (abnormal fetal dopplers), with previous caesarean section, with grade 1 and 2 placenta previa, fetal macrosomia, precious pregnancy, and cephalopelvic disproportion.

Exclusion criteria

Exclusion criteria: A. Pregnant women with complications such as preeclampsia, HELLP syndrome or multiple pregnancies, gestational diabetes, hypothyroidism or with cardiac dysfunction. B. Pregnant women with known co morbidities like diabetes, hypertension, chronic kidney disease, rheumatoid arthritis etc. C. Body mass index (BMI) more than 40 D. Pregnant women with cognitive impairment (unable to assess verbal numeric pain scales); E. Those with contraindications to neuraxial anesthesia, and with preexisting hypersensitivity or allergy to local anesthetics and analgesics used in the study. F. Pregnant women with chronic pain, systemic diseases such as neuromuscular disorders, and chronic use of opioid analgesics

Design outcomes

Primary

Measure	Time frame
I. To compare intraoperative and postoperative shivering between three groups among pregnant women undergoing caesarean delivery II. To compare duration of postoperative analgesia between three groups among pregnant women undergoing caesarean deliveryTimepoint: Every 5 mins intraoperatively Every 30 mins in PACU ward Every 2 hrs in the WARD until 24 hrs	—

Secondary

Measure	Time frame
To compare duration of sensory and motor block between three groups during spinal anesthesia among pregnant women undergoing caesarean deliveryTimepoint: Every 5 mins intraoperatively Every 30 mins in PACU ward Every 2 hrs in the WARD until 24 hrs	—

Countries

India

Contacts

Public ContactDr Nandakumar M

Cloud nine hospitals

drkumarmn@gmail.com9880554350

Outcome results