Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy. (BSCPB_Block)
Primary Purpose
Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Block type
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia Obtained With a Local Wound Infiltration of Lidocain
Eligibility Criteria
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.
Sites / Locations
- Linköping University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bilateral superficial cervical plexus block (BSCPB)
local wound infiltration (LWI)
Arm Description
Analgesia obtained by a ultrasound guided cervical plexus block using lidocain
Analgesia obtained by local wound infiltration of lidocain
Outcomes
Primary Outcome Measures
postoperative opioid consumption in the first postoperative day
postoperative opioid consumption in the first postoperative day in milligrams
Secondary Outcome Measures
total intraoperative fentanyl (mg) and isoflurane consumption (ml)
total intraoperative fentanyl and isoflurane consumption in micrograms and ml
time to first required analgesic
time to first required analgesic
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
Full Information
NCT ID
NCT04993521
First Posted
June 10, 2021
Last Updated
July 28, 2021
Sponsor
University Hospital, Linkoeping
Collaborators
Ahmed Mohamed Abdelrahman, Mahmoud Ahmed Mewafy, Abdelrhman Alshawadfy, Haidi Abd-Elzaher, Hamada Fathy, Mohamed Faisal
1. Study Identification
Unique Protocol Identification Number
NCT04993521
Brief Title
Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.
Acronym
BSCPB_Block
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
Collaborators
Ahmed Mohamed Abdelrahman, Mahmoud Ahmed Mewafy, Abdelrhman Alshawadfy, Haidi Abd-Elzaher, Hamada Fathy, Mohamed Faisal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia Obtained With a Local Wound Infiltration of Lidocain, Analgesia Obtained With a Ultrasound Guided Cervical Plexus Block Using Lidocain, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bilateral superficial cervical plexus block (BSCPB)
Arm Type
Active Comparator
Arm Description
Analgesia obtained by a ultrasound guided cervical plexus block using lidocain
Arm Title
local wound infiltration (LWI)
Arm Type
Active Comparator
Arm Description
Analgesia obtained by local wound infiltration of lidocain
Intervention Type
Procedure
Intervention Name(s)
Block type
Other Intervention Name(s)
Ultrasound guided bilateral superficial cervical plexus nerve block
Intervention Description
Regular block type
Primary Outcome Measure Information:
Title
postoperative opioid consumption in the first postoperative day
Description
postoperative opioid consumption in the first postoperative day in milligrams
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
total intraoperative fentanyl (mg) and isoflurane consumption (ml)
Description
total intraoperative fentanyl and isoflurane consumption in micrograms and ml
Time Frame
6 hours
Title
time to first required analgesic
Description
time to first required analgesic
Time Frame
6 hours
Title
VAS (10 cm; range): Pain average (VAS) for the first 24 hours postoperatively
Description
VAS (10 cm; range) Pain average (VAS) for the first 24 hours postoperatively
Time Frame
every 6 hours until 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Can be shared on reasonable terms
Learn more about this trial
Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.
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