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

Phase 4

Registration Number: CTRI/2024/06/068651

Lead Sponsor: Cloud nine hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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