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Can optimized postoperative pain management improve outcomes after an operation for oesophageal cancer (cancer of the gullet)?

Paravertebral Block AnaLgesia vs. epidural: Assessing Novel Care in Esophagectomy (BALANCE): a multi-center randomized Phase III trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16853684
Enrollment
550
Registered
2026-01-29
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Oesophageal cancer Cancer

Interventions

Randomisation: Participants are enrolled and randomized consecutively as they are found to be eligible for inclusion in the trial. Randomization is performed no later than 12 h before surgery. If a pa

Sponsors

Uppsala University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Adult (=18 years of age) patients undergoing minimally invasive oesophagectomy with gastric conduit reconstruction due to confirmed cancer (cT1 N+ or cT2-4a any N; M0-1)

Exclusion criteria

Exclusion criteria: 1. Epidural analgesia contraindicated, i.e., known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens 2. Use of anticoagulants precluding EDA use 3. No postoperative nasogastric tube 4. No ability to understand the study in terms of risk and benefits (including language difficulties) 5. The participant has any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would, in the judgment of the investigator, pose excess risk associated with study participation or that, in the judgment of the investigator, would make the patient inappropriate for entry into the trial

Countries

Denmark, Finland, Iceland, Italy, Norway, Sweden

Contacts

Public ContactLinnéa Pattersson
jakob.hedberg@surgsci.uu.se+46 (0)6119993

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026