Clinical trial NCT04993521: Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.
Official title: Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia Obtained With a Local Wound Infiltration of Lidocain
Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain
Postoperative Pain
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Ahmed Mohamed Abdelrahman
name: Mahmoud Ahmed Mewafy
name: Abdelrhman Alshawadfy
name: Haidi Abd-Elzaher
name: Hamada Fathy
name: Mohamed Faisal
First posted: 2021-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Study
Primary purpose: TREATMENT

Brief summary: The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy

Detailed description: We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, \> 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment.

Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline.

The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

ASA I-II, and were scheduled for total thyroidectomy

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Exclusion Criteria:

documented allergy to study's intervention, moderate-to-severe obesity, \> 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies.

All patients were required to fill the informed consent before enrollment.

Primary outcomes:
measure: postoperative opioid consumption in the first postoperative day
timeFrame: 24 hours
Secondary outcomes:
measure: total intraoperative fentanyl (mg) and isoflurane consumption (ml)
timeFrame: 6 hours
measure: time to first required analgesic
timeFrame: 6 hours
measure: VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively
timeFrame: every 6 hours until 24 hours postoperatively
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
Study officials:
References: