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

Analgesia Clinical Trial

Official title:

Regional Analgesia Using Ultrasound-Guided Intermediate Cervical Plexus Block or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05577559
• Other study ID #: 9790
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Human Medicine, Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to first call to rescue analgesia	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.	24 hour postoperative
Secondary	The total amount of nalbuphine	The total amount of nalbuphine given to each patient during the first 24h of postoperative period will be recorded	24 hour postoperative
Secondary	Pain intensity	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.	up to 24hs postoperative
Secondary	Total intra-operative fentanyl consumption	Total intra-operative fentanyl consumption by ug excluding induction dose.	intra-operative