A Clinical tiral to compare the effects of two drugs, Fentanyl and Nalbuphine when added in Spinal anaesthesia for patients undergoing cesarean section.

Phase 4

Completed

• Conditions: Other obstetric conditions, not elsewhere classified,

• Registration Number: CTRI/2018/12/016739
• Lead Sponsor: SHANMUGAVALLI E

Brief Summary

This study is a randomized double blind controlled study to compare the efficacy and analgesic effect of intrathecal nalbuphine versus fentanyl as adjuvant to subarachnoid block in cesarean section

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-25
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

ASA Physical statusII Weight between 50 to 80 kilogram Height between 150 to 160 cm Cesarean section.

Exclusion Criteria

ASA Physical status III,IV and V.patients receiving long term analgesic therapy,hypnotics or long term CNS depressants.Peripheral neuropathy.cogulopathy,infction at the site of injection.cardiac,hepatic or renal diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset time of sensry blockade.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Onset time of motor blockade.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Highest level of sensory blockade.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Duration of motor blockade.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Ramsay sedation score in te post operative period.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Analgesic effect.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Two segment regression time.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.
Duration of effective analgesia.	Analgesic effect. | Onset time of sensry blockade. | Onset time of motor blockade. | Highest level of sensory blockade. | Two segment regression time. | Duration of effective analgesia. | Duration of motor blockade.All these parameters will be monitored at 0 mins,2mins,5mins,10mins,15mins,30mins,45mins,60mins,90mins,120mins,150mins,180mins,210mins,240mins,270mins and 300mins. | Ramsay sedation score in te post operative period will be documented.

Secondary Outcome Measures

Name	Time	Method
Intra operative parameters heart rate	Systolic blood pressure

Trial Locations

Locations (1)

Velammal medical college and research institute; 🇮🇳 Madurai, TAMIL NADU, India

Velammal medical college and research institute

🇮🇳Madurai, TAMIL NADU, India

DrRamadevi

Principal investigator

8695752109

rama_rathi86@yahoo.co.in