Intermediate Cervical Plexus Block on Stress Response

NCT ID: NCT06064214

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-01

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)

Detailed Description

Stress response is the name given to the hormonal and metabolic changes which follow injury or trauma. It may lead to changes in the nervous, endocrine and immune systems, and alterations in metabolic processes and functions. The stress response can shift from an adaptive and protective role to a pathogenic occurrence, especially when it is strong and chronic.

Stress hormones, the most prevalent of which is cortisol, have a circadian pattern in which they gradually climb after night sleep to reach a peak at early morning wake-up time, then gradually decline as the day progresses .

This pattern, however, can be disrupted by any stressful situation, such as severe pain from surgery, which has been linked to a progressive rise in cortisol levels both intraoperatively and in the early postoperative period.

Cytokines are group of low molecular weight proteins that modulate the systemic inflammatory response elicited by surgical intervention. Increased levels of proinflammatory cytokines, including interleukin-6 (IL-6) which is the main cytokine responsible for inducing the systemic changes, is an early features of acute injury. Interleukin-6 could be a good marker for research purposes that reflects and compares postoperative stress levels.

Spine surgeries are increasingly being performed as short-stay surgical procedures, and anterior cervical decompression and fusion is one such procedure .Postoperative incisional pain has been described as moderate in intensity, requiring opioid analgesics in most cases. Nonetheless, opioid-related side effects such as nausea, vomiting, and respiratory depression are undesirable in these patients who are at risk for airway problems due to surgical retraction or wound hematoma.

Regional anesthesia inhibits the stress response to surgery and can also influence postoperative outcomes. . The endocrinal stress response to the surgical operation is reduced as a result of inhibiting afferent impulses from the surgical site. Furthermore, a reduction in this type of stress response is seen as a key indicator of a successful regional block.

Intermediate cervical plexus block (CPB) is a safe and simple technique that has been shown to provide good pain relief through blocking all four cutaneous branches of the cervical plexus, as well as sensory and motor branches .Not only Intermediate (CPB) is superior to superficial CPB in terms of effectiveness, but also is safer than deep (CPB) .

There is a paucity of evidence for the effect of bilateral cervical plexus block for anterior cervical spine surgeries. Prior research had employed recovery questionnaire score, 24-h opioid usage and length of hospital stay in assessment of cervical plexus block effectiveness , however estimating the effect of Intermediate (CPB) on stress biomarkers as serum cortisol and interleukien-6 has not been discussed yet

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

block

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

Group Type: EXPERIMENTAL

u/s guided intermediate cervical plexus block

Intervention Type: 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

morphine

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

Group Type: ACTIVE_COMPARATOR

u/s guided intermediate cervical plexus block

Intervention Type: 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

Interventions

u/s guided intermediate cervical plexus block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. 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

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed raafat taha abd el aziz

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

gomaa zohry, professor

Role: PRINCIPAL_INVESTIGATOR

cairo universitey

Locations

Ahmed Raafat

Giza, October, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ahmed raafat, master's

Role: CONTACT

ahmedtaha840@hotmail.com

01278996596

gomaa zohry, professor

Role: CONTACT

Gomaaneel70@icloud.com

01122111165

Facility Contacts

gomaa dr zohrey, md

Role: primary

gomaneel@icloud.com

01278996596 ext. 02

ahmed dr ragab, md

Role: backup

ahmedtr.taha@gmail.com

01119003377 ext. 02

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

cervical plexus block

Identifier Type: -

Identifier Source: org_study_id