Intermediate Cervical Plexus Block on Stress Response

NCT06064214 | Unknown

• 1 other identifier: cervical plexus block
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate the effect of Bilateral Ultrasound-Guided intermediate cervical plexus Block combined with general anesthesia on the stress and inflammatory response in patients undergoing anterior cervical spine surgery (ACSS)

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• • The serum cortisol level 24 hours postoperatively

  All operations will be performed in the morning, taking into consideration circadian rhythm of hormone release. In both groups, venous blood samples to measure serum cortisol level will be collected before surgery as a baseline, then 24 hours post-operative

  pre operative and after 24 hours of operation

Secondary Outcomes (1)

• • The serum interleukien-6 24 hours postoperatively

  pre operative and after 24 hours of operation

Study Arms (2)

block

EXPERIMENTAL

33 patients will receive bilateral u/s guided intermediate cervical plexus block with general anesthesia

Procedure: u/s guided intermediate cervical plexus block

morphine

ACTIVE COMPARATOR

33 patients will receive morphine in a dose of 0.1-0.2 mg/kg to maintain intraoperative analgesia

Procedure: u/s guided intermediate cervical plexus block

Interventions

u/s guided intermediate cervical plexus block PROCEDURE

The patient will be placed in supine position,u/s probe is placed on the lateral neck, overlying the sternomastoid muscle at the level of its midpoint , Once the SCM has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.cervical plexus is visible as a small collection of hypoechoic nodules ( immediately superficial to the prevertebral fascia the needle is passed through the skin, platysma, and investing layer of the deep cervical fascia, and the tip is placed adjacent to the plexus,bupivicaine 0.25% (5-15 mL) is administered to envelop the plexus

block; morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ASA I \& ASA II patients.(The American Society of Anesthesiologists) 2. Age group: from 18 to 65 years old. 3. Patients undergoing anterior cervical discectomy or fixation. 4. Genders eligible for study: both sexes

You may not qualify if:

• Patient refusal.
• Patient Undergoing posterior fixation in addition to anterior.
• An allergy to local anaesthetics.
• Infection at block puncture site.
• Bleeding disorders (Coagulopathy: PTT(partial thromboplastin time) \> 40seconds, INR(international normalised ratio) \> 1.2, platelet count \< 120 x 103 / L.).
• Emergency surgeries \& patients in sepsis

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Raafat

Giza, October, 002, Egypt

RECRUITING

Study Officials

• gomaa zohry, professor

  cairo universitey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed raafat, master's

CONTACT

01278996596; ahmedtaha840@hotmail.com

gomaa zohry, professor

CONTACT

01122111165; Gomaaneel70@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: randomized controlled study

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 3, 2023
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

EG (1)