comparison of pain relief effect of 2 drugs when given with numbing medicine around the nerves coming out of the spinal cord for children undergoing surgeries below belly button

Active, not recruiting

• Conditions: Any child between 1 -10 years presenting for infra umbalical surgery

• Registration Number: CTRI/2017/08/009445
• Lead Sponsor: MS Ramaiah Medical College and Hopsitals

Brief Summary

CAudal epidural analgesia is a very common method of providing analgesia for children undergoing surgeries. It can be used for providing both intraoperative and post operative analgesia. A lot of adjuvant drugs are available for proving extended duration of post operative analgesia when mixed along with local anesthetic for caudal epidural. Ropivacaine is a long acting local anesthetic which in a concentration of 0.2% provides sensory block without motor blockade. Buprenorphine and Nalbuphine are synthetically derived  opioids which provide analgesia without risk of respiratory depression due to its agonist-antagonist properties. the primary purpose of our study is to find out which among the two (nalbuphine and buprenorphine) is a better adjuvant when compared to each other and with plain ropivacaine in terms of duration of post operative analgesia, sedation, and incidence of side effects.

Primary hypothesis : -Nalbuphine is a better adjuvant than buprenorphine when given through epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries

Alternative Hypothesis : - Buprenorphine is a better adjuvant than nalbuphine when given through caudal epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Last Update Posted: 2017-08-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

weight between 3- 20 kilograms American Society of Anesthesiologists physical status 1 and 2 undergoing infraumbalical surgeries under general anesthesia supplemented with caudal epidural analgesia.

Exclusion Criteria

1)patients having neurological, neuromuscular and coagulation disorders 2) patients having infection or deformity at site of caudal epidural injection 3) patients with known allergy to the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
Sedation score
Degree of motor blockade	Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery
Incidence of side effects	Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery

Trial Locations

Locations (1)

M.S.Ramaiah Medical College and Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

M.S.Ramaiah Medical College and Hospitals

🇮🇳Bangalore, KARNATAKA, India

DR Sadasivan S Iyer

Principal investigator

8971026127

sadashivaniyer@gmail.com