A clinical trial to study the effectiveness of two different epidural syringes, balloon syringe and regular syringe, in identifying the epidural space in patients undergoing below umbilical surgeries.

A comparative study using the balloon indicator syringe and Conventional loss of resistance (LOR) syringe to identify the epidural space in adult patients undergoing elective lower abdomen and lower limb procedure - A randomized controlled study,. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061190

Enrollment

292

Registered

2024-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Interventions

Intervention1: BALLOON SYRINGE: Epidural space will be identified using Balloon indicator syringe Control Intervention1: CONVENTIONAL SYRINGE: Epidural space identified using Conventional LOR syringe

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective lower abdomen and lower limb surgical procedures where epidural anaesthesia is indicated. Patient aged 18 years to 65 years. BMI 18-25 kg/m2 ASA I & II .

Exclusion criteria

Exclusion criteria: Emergency procedures. Infection at the injection site. Bleeding disorder or coagulopathy . Deformed spine. Pregnancy. Known allergy to any of the local anesthetic drugs. Patient’s refusal.

Design outcomes

Primary

Measure	Time frame
Number of attempts required to accurately identify the epidural space. Timepoint: 1,2,3,4	—

Secondary

Measure	Time frame
Time taken to identify the epidural space. Number of attempts taken to insert the epidural catheter into the epidural space. Complications like dural puncture and bleeding. Timepoint: From insertion of needle till catheter placement	—

Countries

India

Contacts

Public ContactDr Swetha Ramani C

SRM Medical College and Hospital

swethark@srmist.edu.in9884782554

Outcome results

None listed

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