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

Phase 2/3

Not yet recruiting

• Conditions: Obstetrics, (2) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri,

• Registration Number: CTRI/2023/12/060752
• Lead Sponsor: Jwaharlal Nehru Medical College

Brief Summary

Spinal anaesthesiahas a rapid onset and complete motor blockade  and also simple to perform.It has lower incidence of failed block and the local anaesthetic requirement isless. Hence spinal anesthesia is a preferred anaesthetic technique for lowerabdominal surgeries. Adjuvants to local anaesthetics for intrathecaladministration has some advantages. They have synergistic action & intensify sensory block without increasing sympathetic block, reducedlocal anaesthetic drug dose, better hemodynamic stability with lesser sideeffects.

Fentanyl is a pure mu receptor agonist. The common mu agonist sideeffects are  nausea, vomiting, sedation, urinary retention andrespiratory depression. It is lipophilic in nature, with rapid onset of action following intrathecaladministration. The intrathecal drug administration does not producerespiratory depression. It improves anaesthetic quality without muchcomplications.  Nalbuphine is a mixedkappa agonist and mu antagonist opioid drug, which produces analgesia withoutmuch side effects of mu receptor agonist action.

Levobupivacaine is alocal anaesthetic amide which can produce better sensory and motor block withgood hemodynamic profile than bupivacaine. Levobupivacaine is less cardiotoxic than bupivacaine. (1) Many investigators have studied the characteristics of intrathecalnalbuphine & fentanyl with levobupivacaine.

The purpose of this study is to compare the efficacy of fentanyl & nalbuphine as adjuvants to intrathecal levobupivacaine for post-operativeanalgesia following lower abdominal gynaecological surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-22
• Study Start: 2024-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 levobupivacaine	post operative analgesia will be assessed as the primary outcome and it will be monitored for 2 hrs post spinal anaesthesia

Trial Locations

Locations (1)

Acharya Vinoba Bhave Rural Hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Acharya Vinoba Bhave Rural Hospital

🇮🇳Wardha, MAHARASHTRA, India

Dr Saely Paunikar

Principal investigator

9892132765

saely21@gmail.com