The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
Primary Purpose
Thyroid Surgery
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Capsule and cutaneous blocks
US-intermediate cervical plexus block
Sponsored by
About this trial
This is an interventional other trial for Thyroid Surgery
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists physical status grade I and grade II.
- Euthyroidism after thyroid function tests
Exclusion Criteria:
- Patient refusal.
- Thyroid gland more than 5 cm size.
- Retrosternal extension.
- Planned block neck dissection.
- Neuromuscular diseases
- Hematological diseases.
- Bleeding diseases.
- Coagulation abnormality.
- Psychiatric diseases.
- Drug abuse.
- Local skin infection
- sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Known diaphragmatic motion abnormalities
- major respiratory disease.
- Previous history of cervical surgery.
Sites / Locations
- Oncolgy Center, Mansoura University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capsule and cutaneous blocks
US-intermediate cervical plexus block
Arm Description
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery
15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery
Outcomes
Primary Outcome Measures
Total dose of opioid analgesics used
The total dose of opioid analgesics required in the post-operative periods
Secondary Outcome Measures
Postoperative pain
Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),
Time to first analgesic request
Time to first request for a rescue analgesic
Fentanyl use
Intraoperative use of fentanyl
Rocuronium use
Intraoperative use of rocuronium
Sensory blockade
Assessment of sensory blockade
Diaphragmatic dysfunction
Diaphragmatic dysfunction using ultrasound assessment and possible x ray
Sedation score
Sedation score using Modified Ramsay scale
Patient satisfaction
Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction
Postoperative nausea and vomiting
frequency
Postoperative headache
frequency
Hoarseness of voice
frequency
Dysphagia
frequency
Respiratory difficulty
Peripheral oxygen saturation less than 92%
Full Information
NCT ID
NCT03269890
First Posted
August 29, 2017
Last Updated
September 19, 2020
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT03269890
Brief Title
The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
Official Title
The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
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
Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.
Detailed Description
Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.
Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .
Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsule and cutaneous blocks
Arm Type
Experimental
Arm Description
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery
Arm Title
US-intermediate cervical plexus block
Arm Type
Active Comparator
Arm Description
15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery
Intervention Type
Procedure
Intervention Name(s)
Capsule and cutaneous blocks
Intervention Description
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
Intervention Type
Procedure
Intervention Name(s)
US-intermediate cervical plexus block
Intervention Description
15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.
Primary Outcome Measure Information:
Title
Total dose of opioid analgesics used
Description
The total dose of opioid analgesics required in the post-operative periods
Time Frame
For 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),
Time Frame
For 24 hours after surgery
Title
Time to first analgesic request
Description
Time to first request for a rescue analgesic
Time Frame
For 24 hours after surgery
Title
Fentanyl use
Description
Intraoperative use of fentanyl
Time Frame
For 5 hours after start of anaesthesia
Title
Rocuronium use
Description
Intraoperative use of rocuronium
Time Frame
For 5 hours after start of anaesthesia
Title
Sensory blockade
Description
Assessment of sensory blockade
Time Frame
for 1 hour after surgery
Title
Diaphragmatic dysfunction
Description
Diaphragmatic dysfunction using ultrasound assessment and possible x ray
Time Frame
for 5 hours after performing blockade
Title
Sedation score
Description
Sedation score using Modified Ramsay scale
Time Frame
for 5 hours after performing blockade
Title
Patient satisfaction
Description
Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction
Time Frame
for 24 hrs after surgery
Title
Postoperative nausea and vomiting
Description
frequency
Time Frame
For 24 hours after surgery
Title
Postoperative headache
Description
frequency
Time Frame
For 24 hours after surgery
Title
Hoarseness of voice
Description
frequency
Time Frame
For 24 hours after surgery
Title
Dysphagia
Description
frequency
Time Frame
For 24 hours after surgery
Title
Respiratory difficulty
Description
Peripheral oxygen saturation less than 92%
Time Frame
For 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists physical status grade I and grade II.
Euthyroidism after thyroid function tests
Exclusion Criteria:
Patient refusal.
Thyroid gland more than 5 cm size.
Retrosternal extension.
Planned block neck dissection.
Neuromuscular diseases
Hematological diseases.
Bleeding diseases.
Coagulation abnormality.
Psychiatric diseases.
Drug abuse.
Local skin infection
sepsis at site of the block.
Known intolerance to the study drugs.
Body Mass Index > 40 Kg/m2.
Known diaphragmatic motion abnormalities
major respiratory disease.
Previous history of cervical surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moneir O El-Hefny, MD
Organizational Affiliation
Professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Oncolgy Center, Mansoura University,
City
Mansourah
State/Province
DK
ZIP/Postal Code
53316
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
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