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 breastsurgery.

Phase 3

Completed

• Conditions: Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2021/03/031781
• Lead Sponsor: Dr Porika Prashanth Nayak

Brief Summary

·       PECS is a new interfascial blocktechnique used for providing effective analgesia in the intra-op and post-opperiod in various anterior thoracic wall surgeries.

·       We hypothesized that addition ofdexamethasone as an adjuvant to ropivacaine using US guided PEC block techniquein patients undergoing MRM will prolong the duration and quality of analgesiaas compared to that of ropivacaine plain thus reducing overall opioid consumptionand incidence of side effects associated with opioid administration.

·      A total of 64 patients undergoing elective MRM wererandomized to two Groups, Group-A and Group-B. Group A (Study group) received0.25% ropivacaine 30 ml+ dexamethasone 8mg (2ml) while Group B (Controlgroup):0.25% ropivacaine 30 ml + 2ml Normal saline (NS).

·      The dataobtained was analysed.

·      The demographic variables like age, weight,height, BMI were comparable across the groups and the differences were notstatistically significant.

·      The NRS Score when compared between Group A andGroup B was found to be statistically significant at 2, 4, 6 and 12 hrs in thepost-operative period, NRS score being higher in Group B.

·      Therewas a significant difference between the twogroups in terms of Post-Operative Morphine consumption (p = <0.001), with the mean Post-Operative Morphineconsumption being highest in the Group B.

·       There was no significant difference between both the groups interms of associated side effects like hypotension, Bradycardia and nausea.

·      PECS II provides effective and good qualityanalgesia in patients undergoing elective unilateral MRM with minimal sideeffects and complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study Completion: 2022-07-29
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 64

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

• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total opioid consumption till 12 hours post-operatively.	0 hours(when patient arrived at post-operative care unit), 2 hours, 4 hours, 6 hours and 12 hours

Secondary Outcome Measures

Name	Time	Method
1)Difference in pain scores post-operatively in first 12 hours using numeric rating scale (NRS).	2)Post-operative sedation scores.

Trial Locations

Locations (1)

All india institute of medical sciences, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

All india institute of medical sciences, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Porika Prashanth Nayak

Principal investigator

8328109536

prashnayak123@gmail.com