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

Postoperative Pain Clinical Trial

— BSCPB_Block  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993521
• Other study ID #: BSCPB_Block
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 15, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

ASA I-II, and were scheduled for total thyroidectomy

-

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Block type
Regular block type

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Abdelrhman Alshawadfy, Ahmed Mohamed Abdelrahman, Haidi Abd-Elzaher, Hamada Fathy, Mahmoud Ahmed Mewafy, Mohamed Faisal

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption in the first postoperative day	postoperative opioid consumption in the first postoperative day in milligrams	24 hours
Secondary	total intraoperative fentanyl (mg) and isoflurane consumption (ml)	total intraoperative fentanyl and isoflurane consumption in micrograms and ml	6 hours
Secondary	time to first required analgesic	time to first required analgesic	6 hours
Secondary	VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively	VAS (10 cm; range) Pain average (VAS) for the first 24 hours postoperatively	every 6 hours until 24 hours postoperatively