Ultrasound-Guided Superficial Cervical Plexus Block or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05577559
Collaborator
(none)
50
1
2
5.9
8.4

Study Details

Study Description

Brief Summary

• Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery. Complications are rare but can be serious and even potentially life-threatening if they do occur. Rapid recovery and emergence from general anesthesia are important in cases of anterior cervical spine surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Superficial cervical plexus block
  • Procedure: Cervical Erector spinae block
N/A

Detailed Description

  • Null hypothesis (H0): No difference between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in patients undergoing anterior cervical spine surgery under general anesthesia.

  • Alternative hypothesis (H1): There are differences between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Regional Analgesia Using Ultrasound-Guided Superficial Cervical Plexus Block or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery: A Randomized Trial
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Superficial cervical group

patients will receive bilateral ultrasound guided superficial cervical plexus block using 15 ml of bupivacaine 0.25% for each side.

Procedure: Superficial cervical plexus block
patients will receive bilateral ultrasound guided superficial cervical plexus block using 15 ml of bupivacaine 0.25% for each side.

Active Comparator: Erector spinae group

patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.

Procedure: Cervical Erector spinae block
patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.

Outcome Measures

Primary Outcome Measures

  1. Total intra-operative fentanyl consumption [intra-operative]

    Total intra-operative fentanyl consumption by ug excluding induction dose.

Secondary Outcome Measures

  1. The time to first call to rescue analgesia [24 hour postoperative]

    The time to first call to rescue analgesia (nalbuphine) the time between the end of surgery to first report of postoperative pain. will be recorded.

  2. The total amount of nalbuphine [24 hour postoperative]

    The total amount of nalbuphine given to each patient during the first 24h of postoperative period will be recorded

  3. Pain intensity [up to 24hs postoperative]

    2. Pain intensity using Visual Analouge Scale (VAS) (11). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 15mg nalbuphine (rescue analgesic) will be given if VAS≥4.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patient acceptance.

  • Age (21-60) years old.

  • Both sex

  • American Society of Anesthesiologist physical status I / II

  • Elective anterior cervical spine surgery under general anesthesia.

  • patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:
  • Local infection at site of puncture.

  • Altered mental status.

  • History of allergy to study drugs ( bupivacaine, fentanyl).

  • Patients with chronic pain.

  • Patients with severe hepatic or kidney impairment.

  • Patients having a history of hematological disorders, including coagulation abnormality.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Human Medicine, Zagazig University Zagazig Egypt

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Principal Investigator: Alshaimaa Kamel, MD., Zagazig University, Faculty of Human Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alshaimaa Abdel Fattah Kamel, Assistant professor of Anesthesia, Intensive Care and Pain Management, Zagazig University
ClinicalTrials.gov Identifier:
NCT05577559
Other Study ID Numbers:
  • 9790
First Posted:
Oct 13, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
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 Dec 16, 2022