Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
Primary Purpose
Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided Bilateral superficial cervical plexus block
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Ultrasound Guided Superficial Cervical Plexus Block
Eligibility Criteria
Inclusion Criteria:
- Patients aged 21 to 65 years
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective thyroid surgery.
Exclusion Criteria:
- Patient refusal to participate.
- Patients with history of allergy to local anesthetics.
- Patients with history of chronic use of pain killers .
- Patients presented with mental dysfunction.
- Patients with coagulation disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham Technique
Ultrasound-guided Bilateral superficial cervical plexus block
Arm Description
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).
Outcomes
Primary Outcome Measures
Quality of recovery
Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed .
Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).
Secondary Outcome Measures
Postoperative analgesia
Postoperative analgesia defined by the visual analogue scale score 30 min after arrival to recovery room then after 2, 4, 6, 12, 24 hr. If visual analogue scale˃ 3 , morphine 3 mg will be given .
Opioid consumption
Total post operative opioid requirement will be recorded
Diaphragmatic Excursion
Diaphragmatic Excursion assessed by Ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05476003
Brief Title
Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
Official Title
Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.
Detailed Description
Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.
Several strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.
Ultrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.
Owing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.
Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All blocks will be performed by the same anesthesiologist while the measurements will be recorded by anesthesiologist who has no idea about patient allocation.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham Technique
Arm Type
Sham Comparator
Arm Description
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.
Arm Title
Ultrasound-guided Bilateral superficial cervical plexus block
Arm Type
Active Comparator
Arm Description
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Bilateral superficial cervical plexus block
Intervention Description
This nerve block is typically performed in the supine or semi-sitting position, with the head turned slightly away from the side to be blocked to facilitate operator access.
Under strict aseptic condition, the linear ultrasound transducer should be placed on the lateral neck, overlying the sternocleidomastoid muscle at the level of its midpoint (approximately the level of the cricoid cartilage). Once the sternocleidomastoid muscle has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.
Once the plexus has been identified and using In-Plane approach, the needle is passed from medial to lateral through the skin, platysma and investing layer of deep cervical fascia and the tip is placed adjacent to the plexus.
Following negative aspiration, 1 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic (5ml) is administered to envelop the plexus.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
All patients will be premedicated with Midazolam (0.02mg/Kg).
Primary Outcome Measure Information:
Title
Quality of recovery
Description
Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed .
Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).
Time Frame
24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Postoperative analgesia
Description
Postoperative analgesia defined by the visual analogue scale score 30 min after arrival to recovery room then after 2, 4, 6, 12, 24 hr. If visual analogue scale˃ 3 , morphine 3 mg will be given .
Time Frame
24 hours postoperatively
Title
Opioid consumption
Description
Total post operative opioid requirement will be recorded
Time Frame
24 hours postoperatively
Title
Diaphragmatic Excursion
Description
Diaphragmatic Excursion assessed by Ultrasound
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 21 to 65 years
American Society of Anesthesiologists physical status I or II.
Scheduled for elective thyroid surgery.
Exclusion Criteria:
Patient refusal to participate.
Patients with history of allergy to local anesthetics.
Patients with history of chronic use of pain killers .
Patients presented with mental dysfunction.
Patients with coagulation disorders.
Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.
12. IPD Sharing Statement
Learn more about this trial
Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
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