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Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection

StatusActive, Not Recruiting
PhasePhase 3
Started2015-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-16
critical
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-08 → 2027-08
2026-07-21
minor
Study Status v20
Re-verified, no change to tracked fields
2025-07-21
minor
Study Status v19
Primary completion date2025-08→2026-08
Completion date2025-08→2026-08
2024-09-03
minor
Study Status v18
Primary completion date2024-08→2025-08
Completion date2024-08→2025-08
2023-09-01
minor
Study Status v17
Primary completion date2023-08→2024-08
Completion date2023-08→2024-08
Show 16 earlier versions
2023-02-03
minor
Study Status, Contacts/Locations v16
Study sites3 entries, revised
MemoralMemorial Sloan Kettering Cancer Center (Consent Only)
2022-09-13
minor
Study Status v15
Primary completion date2022-08→2023-08
Completion date2022-08→2023-08
2021-09-13
minor
Study Status v14
Primary completion date2021-08→2022-08
Completion date2021-08→2022-08
2020-09-11
minor
Study Status v13
Primary completion date2020-08→2021-08
Completion date2020-08→2021-08
2020-07-20
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Enrollment target240→231
Study sitesdetails revised at 3 of 3 sites
2019-09-09
minor
Study Status v11
Primary completion date2019-08→2020-08
Completion date2019-08→2020-08
2019-05-22
minor
Study Status, Eligibility v10
Eligibility criteria+78 characters
[...] such that they are unable to walk up two flights of stairs. Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
2019-04-12
minor
Study Status, Contacts/Locations v9
Study sites2→3
2018-10-16
minor
Study Status v8
Re-verified, no change to tracked fields
2018-04-25
minor
Study Status, Eligibility v7
Eligibility criteria-124 characters
[...] 00/μL, or evidence of infection at potential epidural site. Patients with increased suspicion for overt extra-hepatic disease requiring diagnostic laparoscopy prior to liver resection Cirrhotic patients. When incidentally discovered intra-opera [...]
2018-01-12
minor
Study Status v6
Primary completion date2018-08→2019-08
Completion date2018-08→2019-08
2017-01-30
minor
Study Status, Study Design v5
PhasePhase 2/3→Phase 3
Primary completion date2017-08→2018-08
Completion datenot stated→2018-08
2016-11-28
minor
Study Status, Eligibility v4
Eligibility criteria+113 characters
[...] d, but will be followed for primary and secondary endpoints. Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs.
2016-08-30
minor
Study Status v3
Re-verified, no change to tracked fields
2016-02-25
minor
Study Status, Eligibility v2
Eligibility criteria+16 characters
[...] documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or [...]
2015-10-14
minor
Study Status v1
Re-verified, no change to tracked fields
2015-08-12
minor
Original filing
The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.
Trial Details
NCT Number NCT02523443
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Liver Cancer, Pain Management
Enrollment 231 participants
Start Date 2015-08
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-15