In patients undergoing gynaecological surgeries, a comparison will be done between levobupivacaine with nalbuphine and fentanyl for post-operative analgesia administered during spinal anesthesia.

Comparision of Post Operative Analgesia Between Nalbuphine and Fentanyl as adjuvant with intrathecal Levobupivacaine for lower abdominal Gynaecological Surgeries - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060752

Enrollment

Registered

2023-12-26

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: 1- Obstetrics Health Condition 2: N888- Other specified noninflammatory disorders of cervix uteri

Interventions

Intervention1: injection nalbuphine and fentanyl with injection levobupivacaine: post operative analgesia will be monitored for 2 hrs after giveing spinal anaesthesia Intervention2: injection nalbuphi

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age between 35-75 years 2 Lower Abdominal surgeries under Subarachnoid Block 3 Duration of Surgery 2 hours 4 ASA I & II 5 MPC I & II 6 Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: 1 Lack of valid informed written consent 2 ASA grade III and IV 3 Infection at the subarachnoid block injection site 4 Patients with neurological and musculoskeletal disease 5 Patients with bleeding disorders 6 Patients on anticoagulants 7 History of allergy to local anesthetic, Fentanyl and Nalbuphine

Design outcomes

Primary

Measure	Time frame
We are trying to prove the hypothesis that addition of adjuvant 1 mg Inj.Nalbuphine intrathecally to Hyperbaric Levobupivacaine prolongs the duration of post-operative analgesia more as compared 25mcg Inj.Fentanyl intrathecally with hyperbaric levobupivacaineTimepoint: post operative analgesia will be assessed as the primary outcome and it will be monitored for 2 hrs post spinal anaesthesia	—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactSaely Shekhar Paunikar

Datta Meghe Institute of Higher Education and Research

drsusann02@rediffmail.com

Outcome results

None listed

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