Clinical trial NCT06064214: Intermediate Cervical Plexus Block on Stress Response
Official title: Effect of Bilateral Ultrasound-Guided Intermediate Cervical Plexus Block Combined With General Anesthesia on THE Stress Response in Patients Undergoing Anterior Cervical Spine Surgery. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: • The serum cortisol level 24 hours postoperatively
timeFrame: pre operative and after 24 hours of operation
Secondary outcomes:
measure: • The serum interleukien-6 24 hours postoperatively
timeFrame: pre operative and after 24 hours of operation
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Raafat
state: October
Study officials:
affiliation: cairo universitey
name: gomaa zohry, professor
role: PRINCIPAL_INVESTIGATOR
References: