Skip to content

To compare pain relief after giving analgesic injections using dexamethasone as additive to ropivacaine vs plain ropivacaine in chest wall muscle layers in patients undergoing breast surgery.

To compare the analgesic efficacy of ultrasound guided PEC II block using dexamethasone as an adjuvant to ropivacaine vs plain ropivacaine in patients undergoing modified radical mastectomy: a prospective, randomized, double blind, parallel group controlled clinical trial.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031781
Enrollment
64
Registered
2021-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Dexamethasone: Adding 8 mg dexamethasone as an adjuvant to 0.2% ropivacaine vs plain 0.2% ropivacaine in patients undergoing modified radical mastectomy Control Intervention1: Plain rop

Sponsors

Dr Porika Prashanth Nayak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Female patients aged 18 years and above 2)Posted for unilateral elective MRM 3)Belonging to American society of Anaesthesiologists (ASA) grade I, II, III

Exclusion criteria

Exclusion criteria: 1)Patients refusal. 2)Contraindications to regional anesthesia (RA) (bleeding diathesis, infection at the site of block and peripheral neuropathy). 3)Allergy to study drugs. 4)BMI � 35 kg/m2 or body weight � less than 40kg. 5)Chest wall deformity. 6)Patients who have undergone prior breast surgery. 7)Psychiatric patients. 8)Pregnant and lactating patients. 9)Any untoward major intra-operative complication (if any). (severe hypotension, bradycardia any injury to the nerve related to the block)

Design outcomes

Primary

MeasureTime frame
Total opioid consumption till 12 hours post-operatively.Timepoint: 0 hours(when patient arrived at post-operative care unit), 2 hours, 4 hours, 6 hours and 12 hours

Secondary

MeasureTime frame
1)Difference in pain scores post-operatively in first 12 hours using numeric rating scale (NRS). 2)Post-operative sedation scores. 3)Incidence and severity of post-operative nausea and vomiting (PONV). 4)Other adverse events (if any). Timepoint: 0 hours, 2 hours, 4 hours, 6 hours, 12 hours post-operatively.

Countries

India

Contacts

Public ContactDr Porika Prashanth Nayak

All India Institute Of Medical Sciences, RAIPUR

drsaritaramchandani@gmail.com94242-04244

Outcome results

None listed

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