To study the effectiveness of addition of the drug clonidine to the local anesthetic drug ropivacaine for use in ultrasound guided transversus abdominis plane block in adult patients undergoing kidney transplantation surgery

Completed

• Conditions: Adult end stage chronic kidney disease patients undergoing renal transplant surgery

• Registration Number: CTRI/2017/07/009102
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

The primary purpose of the study was to see the effect of addition of clonidine as adjuvant to ropivacaine in transversus abdominis plane block for adult renal transplant recipients in terms of post operative analgesia. Addition of clonidine does not appear to provide additional benefit.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-14
• Study Completion: 2016-09-15
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adult patients undergoing renal transplantation.

Exclusion Criteria

1.Refusal to participate 2.Infection at site of proposed block 3.Hypersensitivity to ropivacaine, clonidine or opioids 4.Inability to understand the functioning and use of Patient Controlled Analgesia (PCA)pump or Visual analogue scale.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative 24 hour intravenous morphine consumption	0 hour,2 hours, 6 hours, 12 hours, 24 hours in post- operative period

Secondary Outcome Measures

Name	Time	Method
Intra-operative total intravenous fentanyl consumption	End of surgery
Post-operative 24 hour pain scores on visual analogue scale (VAS 0-100)	0 hour,2 hours, 6 hours, 12 hours, 24 hours in the post-operative period
Number of boluses of intravenous morphine as rescue analgesia in 24 hour post-operative period	0 hour,2 hours, 6 hours, 12 hours, 24 hours in post-operative period
Time to first analgesic use in the post operative period	Time point at which first analgesic was required in the post-operative period
Side effects in the post operative period such as hypotension (blood pressure less than 25% of baseline), significant bradycardia (heart rate less than 50 beats/minute associated with hypotension),sedation (score more than 3 in Ramsay sedation scale), respiratory depression (respiratory rate less than 8 breath/minute or SpO2 less than 90% with oxygen by face mask), pruritus, post operative nausea and vomiting	0 hour, 2 hours, 6 hours, 12 hours, 24 hours in the post-operative period

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr Sayan Nath

Principal investigator

9560371996

sayannathcmc2@yahoo.com