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Comparison of two concentrations of a drug in management of pain after brain surgery

A Randomized controlled study to assess the efficacy of ropivacaine instillation through subgaleal drain for postcraniotomy pain - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060896
Enrollment
120
Registered
2023-12-28
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: G891- Acute pain, not elsewhere classified Health Condition 2: C713- Malignant neoplasm of parietal lobe

Interventions

Intervention1: GROUP B: 0.1% Ropivacaine(12ml),Once at the time of dural closure,Instillation through subgaleal drain,Total duration of recording data will be 24 hours Intervention2: GROUP C: 0.2% Rop

Sponsors

Uttar pradesh university of medical sceinces saifai etawah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American society of anaesthesiologists (ASA) Physical Status Grade I and II 2. Elective Craniotomy

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Previous Head trauma 3. History of craniotomy 4. Chronic headache (migraine and cluster headache) 5. Glasgow Coma scale (GCS) 6. Active psychiatric disorders 7. Allergy to study drugs 8. Chronic opioid/analgesic abuse 9. Chronic steroid use

Design outcomes

Primary

MeasureTime frame
To Assess postoperative pain by NRS (Numeric Rating Scale) Timepoint: From 0 minute to 24 hours

Secondary

MeasureTime frame
1.To compare the duration of analgesia. 2.To compare the rescue analgesic requirement in 24 hours postoperatively. 3.To compare the postoperative hemodynamic parameters such as Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Oxygen saturation (SPO2) in percentage. 4.To compare the patient satisfaction score. Timepoint: From 0 minute to 24 hours

Countries

India

Contacts

Public ContactPriyanka Bhardwaj

Uttar pradesh medical sciences saifai,etawah

ushashukla1970@gmail.com9412201915

Outcome results

None listed

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