The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedSeptember 22, 2020
September 1, 2020
8 months
August 29, 2017
September 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Total dose of opioid analgesics used
The total dose of opioid analgesics required in the post-operative periods
For 24 hours after surgery
Secondary Outcomes (13)
Postoperative pain
For 24 hours after surgery
Time to first analgesic request
For 24 hours after surgery
Fentanyl use
For 5 hours after start of anaesthesia
Rocuronium use
For 5 hours after start of anaesthesia
Sensory blockade
for 1 hour after surgery
- +8 more secondary outcomes
Study Arms (2)
Capsule and cutaneous blocks
EXPERIMENTAL7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery
US-intermediate cervical plexus block
ACTIVE COMPARATOR15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery
Interventions
7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status grade I and grade II.
- Euthyroidism after thyroid function tests
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncolgy Center, Mansoura University,
Al Mansurah, DK, 53316, Egypt
Study Officials
- STUDY CHAIR
Moneir O El-Hefny, MD
Professor of Anesthesia and Surgical Intensive Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 1, 2017
Study Start
October 1, 2017
Primary Completion
June 1, 2018
Study Completion
September 30, 2018
Last Updated
September 22, 2020
Record last verified: 2020-09