Health TrialsbyHealthPanel

Preoperative Block for Anterior Cervical Spine Surgery

ConditionAnesthesia, Local
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-60
SponsorTanta University

About this trial

The purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery.

* The main questions it aims to answer are:

* The primary outcome will be recording postoperative pain intensity using Numerical Rating Scale (NRS). * The secondary outcomes will be measuring the performance time, onset of the sensory block, intraoperative fentanyl consumption, time to the first call for rescue analgesia (nalbuphine), postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia. * We will compare two blocks to a placebo. * Participants will:

* undergo ultrasound-guided intermediate cervical plexus block or cervical erector spinae block or a placebo * Be assessed for pain after 2 h, 4 h, 6 h, 12 h, and 24 h postoperatively

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both sex

Age: between 21 and 60 years

Physical status: belongs to American Society of Anesthesiologists (ASA) I, II

Body mass index (BMI): from 25 to 30 kg/m2

Disqualifiers

Refusal of participation.

local infection at the puncture site.

Mental or physical disability.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Block for Anterior Cervical Spine Surgery

    Procedure/Surgery

    The patient will be positioned supine with a slight elevation of the head and the head turned away from the blocked side. After sterilizing the skin, the ultrasound probe will be placed over the middle of the posterior border of the sternocleidomastoid muscle. The needle will be inserted in-plane while keeping the probe in a transverse position. The needle tip will be placed under the sternocleidomastoid muscle and below the superficial fascia, and then, a total volume of 15 ml of 0.25% bupivacaine will be injected bilaterally. The spread of the local anesthetic will be visualized using ultrasound guidance. The same steps will be repeated on the other side

  • Saline (NaCl 0,9 %) (placebo)

    Drug

    Total volume of 15 ml of saline 0.9% will be injected subcutaneous bilaterally

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Intermediate cervical plexus blockActive comparator 1 intervention
Group B: Cervical Erector spinae blockActive comparator 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in postoperative pain intensity using Numerical Rating Scale

Numeric Rating Scale ( NRS) score, a commonly used 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme ( pain as bad as you can imagine or worst pain imaginable). The patient will be instructed to mark along the line to represent the intensity of pain currently being experienced.

Time frame
(Day 1) 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperative

Secondary outcomes

1

Change in the time of performance of the technique in minutes.

Time of performance of the technique: the time from probe insertion until the visualization of local anesthetic spread in minutes.

Time frame
Perioperative/Periprocedural
2

Change in the time to the first call for analgesia (nalbuphine) in hours.

The time to the first call for rescue analgesia (nalbuphine), which is the time between the end of surgery and the first report of postoperative pain, will be recorded in hours.

Time frame
Perioperative/Periprocedural
3

The total measure of nalbuphine given to each patient during the first 24 hours of the postoperative period

The total amount of nalbuphine in milligrams given to each patient during the first 24 hours of the postoperative period will be recorded.

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: