A comparative study of nalbuphine and fentanyl as additives to bupivacaine in spinal anaesthesia in patients undergoing TURP surgery

A comparative study of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021013

Enrollment

Registered

2019-09-02

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: null- ASA I AND II PATIENTS UNDERGOING ELECTIVE TURP SURGERIES Health Condition 2: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Control Intervention1: NALBUPHINE: SEMI SYNTHETIC OPIOID, KAPPA AGONIST WITH ADEQUATE DURATION OF SENSORY AND MOTOR BLOCK AND PROLONGED POST OPERATIVE PERIOD OF ANALGESIA WITH MINIMAL SIDE EFFECTS.

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II

Exclusion criteria

Exclusion criteria: 1. ASA grade III or more 2. Patients refusal for subarachnoid block. 3. Patients on anticoagulant medication. 4. History of anaphylaxis to local anaesthetics. 5. Infection at site of injection. 6. patient with spinal deformities.

Design outcomes

Primary

Measure	Time frame
1. onset and duration of sensory block level. 2. onset and duration of motor block level. 3. evaluating haemodynamic parameters. Timepoint: onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.	—

Measure

Time frame

1. onset and duration of sensory block level. 2. onset and duration of motor block level. 3. evaluating haemodynamic parameters. Timepoint: onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.

—

Secondary

Measure	Time frame
1. Duration of post operative analgesia. 2. Side effect profile with each drug. Timepoint: duration of postoperative analgesia to be recorded from the point of spinal injection till the patient first demands rescue analgesia. side effects to be noted both intraoperatively as well as postoperatively.	—

Countries

India

Contacts

Public ContactPalavi Garg

Dayanand Medical College and Hospital,

drkamakshigarg@gmail.com9814444121

Outcome results

None listed

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