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Quality of recovery in breast conservation surgery.

Comparison of quality of recovery, postoperative pain and inflammatory biomarkers amongst opioid free, opioid sparing versus opioid based general anesthesia in breast conservation surgery ? A pilot randomized control study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094051
Enrollment
120
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: C506- Malignant neoplasm of axillary tail of breast Health Condition 2: C509- Malignant neoplasm of breast of unspecified site Health Condition 3: C500- Malignant neoplasm of nipple and areola Health Condition 4: C508- Malignant neoplasm of overlappingsites of breast Health Condition 5: C504- Malignant neoplasm of upper-outerquadrant of breast Health Condition 6: O- Medical and Surgical

Interventions

Intervention1: Opioid sparing group: Opioids, Paracetamol used Intervention2: Opioid Free group: IV Lignocaine Control Intervention1: Opioid Based group: Opioid based bolus and infusion included

Sponsors

Self funded
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18 to 75yrs presenting for breast conservation surgery Consenting to be part of study ASA classified Upfront surgery or Prior NACT and RT Associated sentinel LND

Exclusion criteria

Exclusion criteria: Non-consenting Associated Axillary dissection Mastectomy Reconstructive breast procedures Other comorbidities like psychiatric illness hepatic renal cardiac dysrhythmia pregnancy chronic pain disorders morbid obesity and allergy to Lignocaine

Design outcomes

Primary

MeasureTime frame
Quality of Recovery QOR 15 scoreTimepoint: Quality of Recovery QOR 15 score immediate postoperative period till 48 hours—

Secondary

MeasureTime frame
Pain NRS Inflammatory Biomarkers PCT CRP Postoperative nausea vomiting Patient satisfaction Likert scale PPSP 3m CPSP 6 m Relapse within 1 yr Timepoint: Till 1 year;Pain NRS Inflammatory Biomarkers PCT CRP Postoperative nausea vomiting Patient satisfaction Likert scale PPSP 3m CPSP 6 m Relapse within 1 yr Timepoint: Till 1 year—

Countries

India

Contacts

Public ContactS Ramkiran

Sri Shankara Cancer hospital and research

sramkiran44@gmail.com7263957169

Outcome results

None listed

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