A study to compare the efficacy of local Anaesthetic (Ropivacaine) alone and in combination with opiod or ketamine as adjuvent in periphral nerve block for Pain Relief following Breast surgery

Phase 4

Not yet recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2020/02/023624
• Lead Sponsor: Department of Anaesthesia and Critical Care

Brief Summary

The aim and objective of the thesis is to evaluate Whether ropivacaine alone or in combination with fentanyl or ketamine will be effective analgesics for modified pectoral block in patients following modified radical mastectomy Adult patients aged between 18-60 years of Female sex belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing breast surgery under general anaesthesia will be included in this study and we will asses Intraoperative haemodynamic monitorin,Postoperative haemodynamic monitoring,Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously),Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously),Diclofenac sodium & Tramadol consumption in surgical ward,VAS Score,Nausea score,Sedation score,Side effects observed a)Hypotension b)Bradycardia c) any other and Antiemetics required.Data will be copiled and appropriate stastical test will be done to analyse the result

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-26
• Study Start: 2020-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

All women aged between 20-60 years, belonging to American Society of Anesthesiologists (ASA) physical status I-III undergoing modified radical mastectomy (MRM) under general anaesthesia will be included in this study.

Exclusion Criteria

Patients having contraindication to regional block, history of local anaesthetic allergy, psychiatric disorders, chronic opioid use, chachexic women and refusal to participate in the study will not been included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Intraoperative haemodynamic monitoring	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
2.Postoperative haemodynamic monitoring	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously)	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously)	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
5.Diclofenac sodium & Tramadol consumption in surgical ward	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
6.VAS Score	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
7.Nausea score	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
8.Sedation score	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
9.Side effects observed a)Hypotension b)Bradycardia c) any other	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required
10.Antiemetics required	1.Intraoperative haemodynamic monitoring | 2.Postoperative haemodynamic monitoring | 3.Time of first request for 1st rescue analgesic (injection Diclofenac sodium 75mg intravenously) | 4.Time of first request for 2nd rescue analgesic (injection Tramadol 50mg intravenously) | 5.Diclofenac sodium & Tramadol consumption in surgical ward | 6.VAS Score | 7.Nausea score | 8.Sedation score | 9.Side effects observed a)Hypotension b)Bradycardia c) any other | 10.Antiemetics required

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative haemodynamic monitoring	2.Postoperative haemodynamic monitoring

Trial Locations

Locations (1)

Pt B.D.Sharma PGIMS; 🇮🇳 Rohtak, HARYANA, India

Pt B.D.Sharma PGIMS

🇮🇳Rohtak, HARYANA, India

Dr Davender chahal

Principal investigator

9728069762

jgdchahal@gmail.com