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Completed

NCT Number: NCT04993521

Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Block type

Procedure

Regular block type

Other names: Ultrasound guided bilateral superficial cervical plexus nerve block

Primary outcomes

  1. postoperative opioid consumption in the first postoperative day

    Time frame: 24 hours

    postoperative opioid consumption in the first postoperative day in milligrams

Secondary outcomes

  1. total intraoperative fentanyl (mg) and isoflurane consumption (ml)

    Time frame: 6 hours

    total intraoperative fentanyl and isoflurane consumption in micrograms and ml

  2. time to first required analgesic

    Time frame: 6 hours

    time to first required analgesic

  3. VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively

    Time frame: every 6 hours until 24 hours postoperatively

    VAS (10 cm; range) Pain average (VAS) for the first 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Abdelrhman Alshawadfy
  • Ahmed Mohamed Abdelrahman
  • Haidi Abd-Elzaher
  • Hamada Fathy
  • Mahmoud Ahmed Mewafy
  • Mohamed Faisal

Registry information

Official study title

Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Local Wound Infiltration in Patients Undergoing Total Thyroidectomy: A Randomized Controlled Study

Acronym: BSCPB_Block

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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