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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: intermediate cervical plexus block; Procedure: Cervical Erector spinae block

• Registration Number: NCT05577559
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-13
• Study Start: 2022-11-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superficial cervical group	intermediate cervical plexus block	patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.
Erector spinae group	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Human Medicine, Zagazig University; 🇪🇬 Zagazig, Egypt