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Comparing the effectiveness of different concentrations of Ropivacaine(0.2%,0.33%,0.5%) with Dexamethasone as an adjunct used in scalp nerve block in relation to pain relief post-operatively and Intra-operative vitals stability in patients undergoing elective craniotomy.

Comparing the efficacy of different concentrations of Ropivacaine(0.2%,0.33%,0.5%) with Dexamethasone as an adjunct used in scalp nerve block in relation to Post-operative analgesia and Intra-operative Haemodynamics in patients undergoing elective craniotomy- A Randomized Double Blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053366
Enrollment
150
Registered
2023-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: D330- Benign neoplasm of brain, supratentorial Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: SCALP NERVE BLOCK : Patients posted for elective craniotomy will be randomly allocated into 3 groups by computer generated randomization.After induction of General Anaesthesia different

Sponsors

Dr BASUNDHARA CHAKRABARTI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients scheduled for elective craniotomy under general anesthesia planned for on-table extubation and expected to gain consciousness within 2 hrs. 1) American Society of Anaesthesiologists (ASA) physical status of Iâ??II; 2) Age 18â??60 years; 3) Participants required to fix their head in a head clamp intraoperatively; 4) Participants with an anticipated full recovery within 2 hrs postoperatively.

Exclusion criteria

Exclusion criteria: 1) History of craniotomy; 2) Expected delayed extubation or no plan to extubate; 3) Participants who cannot understand the instructions of a numeral rating scale (NRS) before surgery; 4) Extreme body mass index (BMI) ( 35); and body weight 5) Allergy to opioids, dexamethasone, or ropivacaine; 6) History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects; 7) History of psychiatric disorders, uncontrolled epilepsy or chronic headache; 8) Pregnant or at breastfeeding; 9) Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes; 10) Preoperative Glasgow Coma Scale 11) Suspicion of intracranial hypertension; 12) Peri-incisional infection; 13) Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Design outcomes

Primary

MeasureTime frame
To determine the optimum concentration of ropivacaine with dexamethasone in scalp block to provide longer duration of post operative analgesia for patients undergoing craniotomy.Timepoint: 24 hours—

Secondary

MeasureTime frame
To determine the optimum concentration of ropivacaine with dexamethasone in scalp block to provide intra operative hemodynamic stability and least side effects in patients undergoing elective craniotomy under general anaesthesiaTimepoint: 24 hours—

Countries

India

Contacts

Public ContactBasundhara Chakrabarti

IMS and SUM Hospital

sudeepmohapatra@soa.ac.in9438133915

Outcome results

None listed

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