Intermediate Cervical Plexus Block on Stress Response

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06064214
Collaborator
(none)
66
2
13

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: u/s guided intermediate cervical plexus block
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled studyrandomized controlled study
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: block

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

Procedure: 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

Active Comparator: morphine

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
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

Outcome Measures

Primary Outcome Measures

  1. • The serum cortisol level 24 hours postoperatively [pre operative and after 24 hours of operation]

    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

Secondary Outcome Measures

  1. • The serum interleukien-6 24 hours postoperatively [pre operative and after 24 hours of operation]

    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 and interleukien-6 level will be collected before surgery as a baseline, then 24 hours post-operative.interleukien-6 is normally low and may be undetectable within 30-60 min after start of surgery while reaching maximum level at 24 hours post-operative

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: gomaa zohry, professor, cairo universitey

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ahmed raafat taha abd el aziz, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT06064214
Other Study ID Numbers:
  • cervical plexus block
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 3, 2023