Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

Tanta University

Status: Not yet enrolling

Conditions: Enhanced Recovery; Thyroid Surgery; Bilateral Ultrasound Guided Superficial Cervical Plexus Block

Treatments: Drug: Midazolam; Procedure: Ultrasound-guided Bilateral superficial cervical plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT05476003

34751/6/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Sham Technique

Sham Comparator group

Description:

Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.

Treatment:

Drug: Midazolam

Procedure: Ultrasound-guided Bilateral superficial cervical plexus block

Ultrasound-guided Bilateral superficial cervical plexus block

Active Comparator group

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).

Treatment:

Drug: Midazolam

Procedure: Ultrasound-guided Bilateral superficial cervical plexus block