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Clinical Trials/CTRI/2022/07/044429
CTRI/2022/07/044429Not yet recruitingPhase 3

A COMPARISON OF EFFECTS OF ULTRASOUND-GUIDED INTERMEDIATE CERVICAL PLEXUS BLOCK AND LOCAL ANAESTHETIC INFILTRATION ON HEMODYNAMIC RESPONSE AND PERIOPERATIVE ANALGESIA IN PATIENTS UNDERGOING EXCISION OF CEREBELLOPOTINE ANGLE TUMORS WITH RETROMASTOID SUBOCCIPITAL CRANIOTOMY (RMSOC)

Nizams Institute of Medical Sciences1 site in 1 country60 target enrollmentStarted: January 8, 2022Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Hemodynamics at pin insertion, skin incision and dural opening

Study Overview

Brief Summary

This is a prospective randomized controlled trail comparing the effect of ultrasound guided intermediate cervical plexus block and scalp block versus local anesthetic infiltration and scalp block on hemodynamic response and peri operative analgesia in patients umdergoing excision of cerebellopontine angle tumors with retromastoid suboccipital craniotomy. Total of 60 patients will be recruited with 30 in each group, group C - patients recieving ultra sound guided intermediate cervical plexus block and scalp block and group I - patients receiving local anaesthetic infiltration and scalp block.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged between 18 to 60YEARS 2)Patients of both gender 3)Patients with ASA grade 1 and 2 4)Patients with Weight 40 to 80kg 5)Patients with any CP angle tumor with GCS-15.

Exclusion Criteria

  • Patients with known respiratory and cardiac problems 2)Patients with Congenital Diaphragmatic problems 3)Local sepsis 4)Bleeding diathesis 5)Hypersensitivity to local anaesthetics 6)Duration of surgery more than 4 hours.

Outcomes

Primary Outcomes

Hemodynamics at pin insertion, skin incision and dural opening

Time Frame: 1 year

Secondary Outcomes

  • Post operative analgesia as assessed by visual Analogue Scale,(SpO2, EtCO2, entropy)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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