To compare effects of two heavy local anaesthetics in patients undergoing gynecological surgeries under spinal anaesthesia.

Comparison of Hyperbaric Ropivacaine versus Hyperbaric Bupivacaine in subarachnoid block for gynecological surgery - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059198

Enrollment

Registered

2023-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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: Hyperbaric Ropivacaine: Single injection of Hyperbaric Ropivacaine 15 mg in the subarachnoid space producing subarachnoid block for duration of 2.5 hours in total of 38 patients over a

Eligibility

Inclusion criteria

Inclusion criteria: Age group between 18-65 years American Society of Anaesthesiologists (ASA) physical status I and II of either sex BMI = 20 to = 35kg/m² Duration of surgery upto 2-2.5 hours in gynecological surgeries (I.e Vaginal hysterectomy, Cervical polypectomy, Tubal recanalisation, Myomectomy, Dilatation and evacuation)

Exclusion criteria

Exclusion criteria: Pre- existing local infection at the site of subarachnoid block Patients with coagulopathy and platelet disorders Contraindication or allergy to study drugs Patients having pain in any other area than the surgery site Patients having sensory or motor problem in the lower limb Patients who failed to understand the VAS scoring system Pregnant and lactating women Patients with current history of psychiatric illness, communication difficulties

Design outcomes

Primary

Measure	Time frame
Comparison of duration of motor block after injecting the drugs intrathecally Assessment of sensory block will be done using sterile pin prick method and motor block will be assessed using Modified Bromage scale. Timepoint: Time interval from onset of motor block to attainment of complete movements (Bromage 0) in both lower limbs-motor blockade will be assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery and every 15 minutes postoperatively.	—

Measure

Time frame

Comparison of duration of motor block after injecting the drugs intrathecally Assessment of sensory block will be done using sterile pin prick method and motor block will be assessed using Modified Bromage scale. Timepoint: Time interval from onset of motor block to attainment of complete movements (Bromage 0) in both lower limbs-motor blockade will be assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery and every 15 minutes postoperatively.

—

Secondary

Measure	Time frame
Comparison of onset of sensory and motor block, peak level, time to 2 segment regression, duration of effective analgesia and any side effects of drug or procedureTimepoint: Sensory and motor blockade will be assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery and every 15 minutes postoperatively.	—

Countries

India

Contacts

Public ContactDr Jasveer Singh

Government Medical College and Hospital, Chandigarh

drjassy18@gmail.com9646121664

Outcome results

None listed

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