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A study to reduce pain after breast surgery in breast cancer patients by giving pain relieving injections during the surgery

The effect of direct vision deep serratus anterior plane block on postoperative pain in breast surgeries: A randomised double blind placebo control trial (SEAN Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054681
Enrollment
90
Registered
2023-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: SAPB (Serratus Anterior Plane Block)under vision: The serratus anterior plane block will be conducted by injecting 20 ml of 0.25 % of levobupivacaine ,through the incision, deep to serr

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18â??80 years 2. ASA 1 and 2 3. All patients posted for mastectomy after chemotherapy. (post chemo mastectomy which donâ??t require peritumoral lignocaine infiltration)

Exclusion criteria

Exclusion criteria: 1. Severe cardiac disease (ischemic/valvular/failure related) which limit the functional activities of the patient. We will exclude the patients with cardiac disease with effort tolerance less than 2 floors. 2. History of chronic kidney disease, or current deranged renal functions (Current creatinine >1.2) 3. History of liver disease, or current deranged liver functions (Current AST /ALTs >2 times of normal.) 4. Patients on preoperative opioids, both strong and weak opioids like Tramadol, codeine. 5. History of allergy or contraindication to local anesthetics 6. Breast Conservative Surgeries

Design outcomes

Primary

MeasureTime frame
To compare maximum NRS pain scores in patient receiving SAPB with patients receiving a placebo drug (saline) upto 24 hours.Timepoint: At 1 hr, 2 hrs & until 24 hrs

Secondary

MeasureTime frame
1) Time of requirement of 1st rescue analgesic. 2) The occurrence of PONV within 24 hours postoperatively. 3) Sedation score 4) Comparison of NRS pain scores at 1 hour, 2 hour & next day morning post surgery. 5) Total opioid consumption (in Fentanyl equivalents) in 24 hours 6) Total opioid consumption after surgery (in fentanyl equivalents) till next day morning Timepoint: At 1 hr, 2 hrs & until 24 hrs

Countries

India

Contacts

Public ContactDr Shubham D Krishan

Tata Memorial Centre

drsheetalvgaikwad@gmail.com9422604296

Outcome results

None listed

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