Multifidus Cervicis and Inter-Semispinal Plane Blocks in Analgesia After Cervical Spine Surgery

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06083298
Collaborator
(none)
105
1
3
11.4
9.2

Study Details

Study Description

Brief Summary

Major spine surgery with multilevel instrumentation is followed by a large amount of opioid consumption, significant pain, and difficult mobilization Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention in rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily activity. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).

Numerous regional anesthetic techniques have been used to provide analgesia following cervical spine surgery, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for such surgeries.

Up to the author's knowledge, there is no study done to compare multifidus cervicis plane block versus inter-semispinal plane block in a randomized controlled clinical trial as preemptive analgesia in patients undergoing cervical spine surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: control group
  • Procedure: MCP group
  • Procedure: ISP group
N/A

Detailed Description

Spine surgeries are commonly associated with severe postoperative pain, particularly complex procedures such as laminectomy on more than two disc levels, or scoliosis surgery, especially on the first postoperative day. Spinal foraminal stenosis and disc herniation, occurring often around C5-C7 levels, are the most popular underlying pathologies of the cervical spine.

One of the keys to a patient's recovery following cervical spine surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioid consumption and improving early mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, cervical paravertebral block, cervical plexus block, cervical erector spinae plane blocks, and local infiltration analgesia. However, some of these techniques have specific limitations that prevent them from being the analgesic technique of choice for cervical spine surgery, and the others are still under research for its effectiveness.

Several new paraspinal blocks have been described in the thoracic and lumbar regions in which the dorsal rami of cervical nerves can be blocked without the block needle entering the paravertebral space. Moreover, novel cervical region blocks, including cervical interfascial plane (CIP) block, multifidus cervicis plane block (MCP), inter-semispinal plane (ISP) block, and retrolaminar cervical block have been developed. All these interfascial plane blocks are considered as promising alternatives to neuraxial blockade for various surgeries.

Multifidus cervicis plane (MCP) block First described by Ohgoshi et al. as a case report for analgesia after cervical laminoplasty, where the local anesthetic was injected between the multifidus cervicis and semispinalis cervicis muscles fascial planes at C5 level. Furthermore, MCP block was effective in another study as a treatment for cervicogenic headaches.

The inter-semispinal plane (ISP) block is also described by Ohgoshi et al., by injecting local anesthetic into the fascial plane between the semispinalis cervicis and capitis muscles and it effectively blocked multiple dorsal rami of the cervical spinal nerves in healthy volunteers.

This study will be designed for evaluation and comparison between Multifidus cervicis and inter-semispinal plane blocks as pre-emptive analgesia for patients undergoing cervical spine surgery under general anesthesia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between Multifidus Cervicis and Inter-semispinal Plane Blocks in Analgesia After Cervical Spine Surgery: A Randomized Controlled Trial
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control group

patients will be operated under general anesthesia

Procedure: control group
patients will be operated under general anesthesia

Active Comparator: MCP group

patients will receive MCP block followed by general anesthesia

Procedure: MCP group
patients will receive ultrasound-guided MCP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Active Comparator: ISP group

patients will receive ISP block followed by general anesthesia

Procedure: ISP group
patients will receive ultrasound-guided ISP block with 15 ml of bupivacaine 0.25% on each side followed by general anesthesia.

Outcome Measures

Primary Outcome Measures

  1. changes in Visual analogue scale (VAS)score [measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively]

    On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

Secondary Outcome Measures

  1. Total dose of rescue analgesia [in the first 24 hour postoperatively]

    once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg nalbuphine will be given and the total dose consumed will be recorded

  2. the first time to rescue analgesia [in the first 24 hour postoperatively]

    the time from the end of operation to patient reporting VAS ≥ 3

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient acceptance.

  • Age 21-60 years old.

  • BMI ≤ 30 kg/m2

  • ASA I - II.

  • Elective posterior cervical spine surgery under general anesthesia.

Exclusion Criteria:
  • History of allergy to the LA agents used in this study

  • Skin lesion at the needle insertion site,

  • Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders

  • History of chronic pain and taking analgesics

  • History of cognitive dysfunction or mental illness

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine, zagazig university Zagazig Alsharqia Egypt 4115

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Principal Investigator: Shereen E Abd Ellatif, MD, Faculty of medicine, zagazig university

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shereen Elsayed Abd Ellatif, associate professor of anesthesia and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier:
NCT06083298
Other Study ID Numbers:
  • 10952//15-8-2023
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 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
Keywords provided by Shereen Elsayed Abd Ellatif, associate professor of anesthesia and surgical intensive care, Zagazig University

Study Results

No Results Posted as of Oct 13, 2023