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Study to Evaluate Safety and Clinical Performance of Epidural Catheter in Patients Requiring Epidural Anesthesia or Analgesia During Routine Clinical Practice.

Epidural Catheter PMCF study: A Prospective, Open Label, Multi-Centre, Single Arm, Observational, Post Marketing Clinical Follow-Up Study to Evaluate Safety and Clinical Performance of Epidural Catheter in Patients Requiring Epidural Anesthesia or Analgesia During Routine Clinical Practice. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037328
Enrollment
105
Registered
2021-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O746- Other complications of spinal andepidural anesthesia during labor and delivery

Interventions

Intervention1: Epidural catheter (from Epidural Mini-pack Kit): Dose:NA, Frequency: NA, Duration of Therapy: Standard of Care Control Intervention1: NA: NA

Sponsors

Global Medikit Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient aged greater than or equal to 18 to less than or equal to 75 years at the time of enrolment. 2. Patient who receive epidural anesthesia/analgesia or post-surgery analgesia using epidural catheter (from Epidural Mini-pack Kit) by the investigator/treating physician during routine clinical practice. 3. Patients with American Society of Anaesthesiologists (ASA) physical status I-III. 4. Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent. 5. Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations.

Exclusion criteria

Exclusion criteria: 1. Patient with contraindications for epidural anesthesia mentioned in the IFU or patients undergoing unscheduled/emergency surgeries 2. Anatomical deformities/wound/scar at puncture site 3. Localized infection at puncture site, or general infection (septicaemia) 4. Hypersensitive or allergic to local anaesthesia and/or any material used for that purpose 5. Currently participating in another clinical study with experimental drugs or devices 6. Active SARS-CoV-2 infection known to patient at the time of enrolment in the study/ patients having signs and symptoms of SARS-CoV-2 infection at the time of enrolment

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate safety associated with epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.Timepoint: During Index procedure, Day - 1. Week 1 plus or minus 1 day.—

Secondary

MeasureTime frame
The secondary objective is to evaluate clinical performance of the epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.Timepoint: During Index procedure, Day 1—

Countries

India

Contacts

Public ContactDr Jatin Soni

Eupraxia Centre For Clinical Excellence LLP

jsoni@eupraxiaconsulting.com9630635333

Outcome results

None listed

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