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

A study to compare the efficacy of ropivacaine alone and in combination with fentanyl or ketamine in modified pectoral block (PEC II) for analgesia following modified radical mastectomy (MRM)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023624

Enrollment

Registered

2020-02-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Modified pectoral blockPEC II is given for analgesia in Modified Radical Mastectomy with Ropivacaine alone: Requirement of rescue analgesic in modified pectoral block PEC II for analges

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 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	—

Measure

Time frame

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 Timepoint: 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

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Secondary

Measure	Time frame
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 Timepoint: The following outcome messures will be assesed in all the three groups 1.Ropivacaine alone 2.Ropivacaine plus Fentanyl 3.Ropivacaine plus Ketamine after giving modified pectoral blockPEC II for analgesia in Modified Radical Mastectomy intra operatively and post operatively for 24 hrs.	—

Measure

Time frame

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 Timepoint: The following outcome messures will be assesed in all the three groups 1.Ropivacaine alone 2.Ropivacaine plus Fentanyl 3.Ropivacaine plus Ketamine after giving modified pectoral blockPEC II for analgesia in Modified Radical Mastectomy intra operatively and post operatively for 24 hrs.

—

Countries

India

Contacts

Public ContactDr Davender Chahal

Department of Anaesthesia and Critical Care Pt B.D.Sharma PGIMS

jgdchahal@gmail.com9728069762

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026