A study to compare efficacy of injection of Ropivacaine plus Fentanyl and Ropivacaine plus Tramadol in spinal anaesthesia

A clinical prospective, double blinded randomized controlled study to compare Intrathecal Hyperbaric Ropivacaine Hydrochloride 0.75%(3ml) plus Fentanyl with Intrathecal Hyperbaric Ropivacaine Hydrochloride0.75%(3ml) plus Tramadol for infraumbilical surgeries.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053362

Enrollment

100

Registered

2023-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: K353- Acute appendicitis with localizedperitonitis Health Condition 2: N211- Calculus in urethra Health Condition 3: N701- Chronic salpingitis and oophoritis Health Condition 4: S720- Fracture of head and neck of femur Health Condition 5: S828- Other fractures of lower leg Health Condition 6: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Intrathecal Ropivacaine plus fentanyl or tramadol: Intrathecal Ropivacaine heavy 3ml plus fentanyl0.5ml versus intrathecal Ropivacaine heavy 3ml plus tramadol0.5ml for infraumbilical su

Eligibility

Inclusion criteria

Inclusion criteria: 1 All patients of age group between 20 and 60 years of either sex. 2 Patients belonging to American Society of Anaesthesiologists (ASA ) grade I and grade II. 3 Patients posted for infraumbilical surgeries.

Exclusion criteria

Exclusion criteria: 1.ASA Grade >=III 2.Mental retardation (congenital anomaly) patients 3.Those with bleeding disorders and local sepsis, 4.Those on anti-coagulants and anti-platelet agents, 5.Those allergic to local anesthetic, 6.Patient refusal for the procedure and technical difficulties

Design outcomes

Primary

Measure	Time frame
Duration of analgesia Post operative analgesic requirement. incidence of shivering. Side effects if any like Pruritus, Hypotension, Bradycardia,Shivering Timepoint: 24months	—

Secondary

Measure	Time frame
Duration of analgesia & requirement of rescue analgesiaTimepoint: 24months	—

Countries

India

Contacts

Public ContactManikrindi Noorjahan

Pacific medical college and hospital

Prakash.audichya10@gmail.com9929721889

Outcome results

None listed

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