Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108508430440 Date of Approval: 17/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intermediate cervical plexus block vs. wound infiltration for thyroidectomy
Official scientific title Comparison of bilateral ultrasound-guided intermediate cervical plexus block vs local wound infiltration for postoperative analgesia in patients undergoing total thyroidectomy.
Brief summary describing the background and objectives of the trial Thyroidectomyis one of the most common surgeries performed worldwide for a number of benign and malignant conditions. Postoperative pain after thyroid surgery is moderate in intensity with postoperative pain scales ranging from 6 to 7/10 on a visual analogic scale. Up to 90% of patients require narcotic analgesics on the first day after surgery. Hence, this study is designed to assess the efficacy of bilateral intermediate cervical plexus block (ICPB) in comparison with local wound infiltration (LWI) in reducing post-operative pain and additional opioid requirement within the first 24 h after surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/08/2021
Actual trial start date 15/08/2021
Anticipated date of last follow up 15/09/2021
Actual Last follow-up date 15/09/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FAMSU M S 23 2021 Research ethical committee, Faculty of medicine, Ain Shams University
Research ethical committee, Faculty of medicine, Ain Shams University
FAMSU M S 23 2021 Research ethical committee, Faculty of medicine, Ain Shams University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group LWI group Patient will receive local wound infiltration with 20 ml bupivacaine 0.25% by the surgeon immediately before extubation Patient will receive local wound infiltration with 20 ml bupivacaine 0.25% immediately before extubation by the surgeon for pain control. 20 Active-Treatment of Control Group
Experimental Group ICPB 10 ml of 0.25% bupivacaine will be injected without exceeding the toxic dose 3 mg/kg The same will be repeated on the contralateral side. immediately before extubation The patient will be placed in supine position, with the head slightly turned to the opposite side to the puncture under complete aseptic precautions. A linear ultrasound probe protected by a sleeve initially will be placed at the level of the hyoid bone to visualize the vascular axis of the neck. Then, it will be moved in the cephalic direction until the visualization of the carotid bifurcation. Subsequently, a lateral scan will be made with respect to the vascular axis to visualize the body of the sternocleidomastoid muscle (SCM) which will be separated from the deep muscles of the neck by a hyperechoic space corresponding to the posterior cervical space where the various branches of the superficial cervical plexus. In plane technique will be used and the needle will be advanced posterior to the lateral edge of the SCM muscle the needle is advanced in plane at the C4 level between the anterior border of elevator scapulae muscle and posterior border of the sternocleidomastoid muscle to reach the posterior cervical space in which the local anesthetic solution is injected 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 18-65 years. 2. Sex: Both sexes. 3. American Society of Anesthesiologists (ASA) Physical Status Class-I and II. 4. Scheduled for elective thyroidectomy under general anaesthesia. 1. Patient refusal 2. Bleeding diathesis. 3. Known diaphragmatic motion abnormalities. 4. COPD 5. Infection at the puncture site 6. Severe hypertension or any severe systemic illness 7. Allergy to local anaesthetics 8. Preexisting peripheral nerve neuropathies 9. Retrosternal goiter 10.Pregnancy 11.Previous cervical surgery. 12.Psychiatric disorder. 13.Chronic Analgesics abusers Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/02/2021 Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Ramsis st., Abbasia, Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.
Secondary Outcome Time to first postoperative analgesia the time from recovery to the first given dose of meperidine
Secondary Outcome Number of patients needed rescue analgesia. for 24 hours postoperatively.
Secondary Outcome The total dose of meperidine used postoperatively (rescue analgesia) for 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University Ramsis Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Sayed Ali Sultan Ramsis, Abbasia Cairo Egypt
Shrouk Mohamed AbdAllah Ramsis, Abbasia Cairo Egypt
Walid Hamed Nofal. Ramsis, Abbasia Cairo Egypt
Mohamed AbdElMohsen AbdElNaeim Ismaiel Ramsis, Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams university Ramsis st. Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shrouk Mohamed AbdAllah Ramsis, Abbasia Cairo Egypt
Walid Hamed Nofal Ramsis, Abbasia Cairo Egypt
Mohamed AbdElMohsen AbdElNaeim Ismaiel Ramsis, Abbasia Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr Ciry
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 9 months and ending 36 months following article publication internet search by keywords
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information