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A clinical trial to study the effect of two drugs , fentanyl , a drug used for pain relief and magnesium, another drug used for pain relief with bupivacaine , a drug used for providing anaesthesia in patients undergoing surgery on lower abdomen

EFFECT OF ADDITION OF INTRATHECAL PRESERVATIVE FREE MAGNESIUM SULPHATE WITH 0.5% BUPIVACAINE HEAVY AND FENTANYL WITH 0.5% BUPIVACAINE HEAVY ON POST OPERATIVE PAIN RELIEF IN PATIENTS UNDERGOING HYSTERECTOMY : A PROSPECTIVE RANDOMIZED CLINICAL EVALUATION

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045255
Enrollment
60
Registered
2022-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Fentanyl with bupivacaine: Fentanyl(25mcg) intrathecally with 0.5% bupivacaine heavy in patients undergoing hysterectomy Control Intervention1: Magnesium sulphate with bupivacaine: Pres

Sponsors

Ankita Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Patient undergoing hysterectomygiving consent to participate in study � Age between 18-60 years ASA grade I and II

Exclusion criteria

Exclusion criteria: � Patients not giving consent to participate in the study. � ASA grade III and IV � Patients with respiratory, cardiovascular, hepatic and renal diseases, obesity and pregnancy. � Age below 60 years. � Any bleeding disorder and patient on anticoagulants. � Neurological and musculoskeletal disease. � Local infection at the injection site. � Patient already receiving magnesium. � Patient already receiving opioid agonist or antagonist in preceding 6 hrs of surgery

Design outcomes

Primary

MeasureTime frame
1. Expected early onset of sensory and motor blockade with the addition of intrathecal fentanyl on comparison with magnesium . 2. Expected prolonged duration of analgesia with the addition of intrathecal fentanyl. Timepoint: Intraoperative and postoperative

Secondary

MeasureTime frame
3. Expected stable haemodynamic profile and lesser side effects with intrathecal magnesium.Timepoint: Intraoperative and postoperative

Countries

India

Contacts

Public ContactDr Ankita Gupta

Gajra Raja Medical College

dr.neelimatandon21@gmail.com9826215586

Outcome results

None listed

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