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A study to test a new method of pain relief for patients being operated for esophageal cancer (cancer of foodpipe)

A prospective interventional pilot study comparing pain relief following an ultrasound-guided Serratus Anterior Plane block in patients undergoing minimally invasive esophagectomy at a tertiary care cancer center, versus retrospectively collected data on standard acute pain management practices - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081913
Enrollment
40
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K20-K31- Diseases of esophagus, stomach and duodenum Health Condition 3: C15-C26- Malignant neoplasms of digestive organs

Interventions

Intervention1: Serratus Anterior Plane (SAP) BLOCK: SAP block will be given in a bolus dose of 0.4 mL/kg of 0.125% of levo-bupivacaine at the end of the surgery with the use of ultrasonography. Contro

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years undergoing MIS esophagectomy

Exclusion criteria

Exclusion criteria: 1. Patient s refusal. 2. Infection at the site of needle insertion. 3. Previous allergic reactions to local anaesthetic (levobupivacaine) and/or paracetamol and/or diclofenac and/or fentanyl. 4. Contraindications to receive paracetamol (liver enzymes more than 5 times the normal values, Child- Pugh B or C) or diclofenac (serum creatinine more than 1.5 mg percent, single-kidney status, blood loss during the surgery more than 1.5 litres, history of aspirin-induced bronchial asthma) 5. Pregnant Women. 6. Patients whom thoracic epidural is inserted with likely high chances of risk of converting into open thoracotomy.

Design outcomes

Primary

MeasureTime frame
NRSTimepoint: NRS- at rest, NRS- on maximal spirometry effort at 1st 4 hours, 4-12 hours, and 24 hours after reaching the recovery room in the postoperative period

Secondary

MeasureTime frame
1. Time to receive the first rescue analgesic following the MIS esophagectomy surgery. 2. Worst pain score in 24 hours following the surgery. 3. Maximal spirometry effort (average of three attempts) at 0-4 hours, 4-12 hours, and 24 hours following the MIS esophagectomy surgery. 4. The total dose of opioids in terms of morphine equivalent (including intraoperative dose) received in the first 24 hours following the MIS esophagectomy surgery. Timepoint: Within 24 hours of surgery

Countries

India

Contacts

Public ContactDr Yash Goel

Tata Memorial Centre

bindi02@gmail.com9764924231

Outcome results

None listed

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