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.: PACTR202403682323400 Date of Approval: 28/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined superficial and deep cervical plexus block versus patient-controlled analgesia (PCA) in patients undergoing total laryngectomy
Official scientific title Combined superficial and deep cervical plexus block versus patient-controlled analgesia (PCA) in patients undergoing total laryngectomy; a comparative study
Brief summary describing the background and objectives of the trial Pain is one of the most common anxieties before and after surgery. It has been reported that pain in head and neck cancer patients has a nociceptive origin due to the direct invasion and destruction of soft tissue and bone tissue by local invasion, but it can also be of neuropathic origin due to inflammation or compression of nervous structures. Adequate pain control is key for successful recovery after major head and neck surgery. It can shorten hospital stay, improve short-term postoperative outcome, and decrease morbidity. The cervical plexus block (CPB) provides effective anesthesia and analgesia for the head and neck region. Patient-controlled analgesia (PCA) has been used ,since 1971, to optimize pain relief. Its goal is to efficiently deliver pain relief at a patient’s preferred dose and schedule by allowing them to administer a predetermined bolus (dose on-demand) by button press. Intravenous PCA with continuous infusion of opioids is widely used in acute postoperative pain management. PCA has been associated with high satisfaction rate. Using PCA pumps postoperatively decreases total opioid consumption and increases patient satisfaction. We hypothesize that combined bilateral superficial and deep cervical block (CPB) would be more effective than patient-controlled analgesia (PCA) in providing postoperative analgesia in patients undergoing total laryngectomy. The aim of this study is to compare efficacy of combined bilateral superficial and deep cervical block relative to patient-controlled analgesia (PCA) regarding; postoperative analgesia in terms of postoperative pain score (measured by visual analogue score (VAS) at 2, 4, 6, 12, 18 and 24 hours postoperatively) and opioid consumption in the first 24 hours postoperatively, in patients undergoing total laryngectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Ear, Nose and Throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Postoperative analgesia and cervical plexus block.
Anticipated trial start date 01/03/2024
Actual trial start date
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 22
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Mansoura 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 Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group1 CPB Cervical Plexus Block Superficial cervical plexus block: 10 ml bupivacaine (0.25%) and 0.5 μg/kg dexmedetomidine will be injected on each side. Deep cervical plexus block: 9 ml bupivacaine (0.25 %) and 0.5 μg/kg dexmedetomidine will be injected on each side. After the induction of general anesthesia. In CPB group, after the induction of general anesthesia, bilateral superficial cervical plexus block (SCPB) will be performed by an anesthesiologist guided by portable ultrasound unit after complete aseptic sterilization of the neck and covering the probe with a sterile sheath. The site of needle insertion for block is the midpoint of the posterior border of the sternocleidomastoid muscle. The needle is positioned under the sternocleidomastoid muscle below the prevertebral fascia. Then, 10 ml of local anesthetic (LA) mixture, consisting of 10 ml bupivacaine (0.25%) and 0.5 μg/kg dexmedetomidine, will be injected in each side. Then, bilateral deep cervical plexus block (DCPB) will be performed by placing the patient in supine position, with the head turned to one side. Under complete aseptic sterilization of the neck and covering the probe with a sterile sheath, the ultrasound probe will be placed along a line joining the mastoid process and Chassaignac’s tubercle. Starting at the mastoid process, the probe will be moved caudally until the vertebral artery loop is visualized. Under ultrasound guidance, the needle is advanced until contact is made with the transverse process (posteroinferior to the artery), then after negative aspiration, 3 ml of local anesthetic mixture (9 ml bupivacaine (0.25 %) and 0.5 μg/kg dexmedetomidine) will be injected. 25
Control Group Group2 PCA Patient Controlled Analgesia Fentanyl (5 μg/ml) solution with a basal infusion of 15 μ/h, and bolus doses of 2 ml/dose (10 μ/dose) with a 15-minute lockout interval. After surgery. In PCA group, all patients will receive general anesthesia during operation. After surgery, intravenous patient-controlled analgesia (PCA) will be provided to the patients. Patients will receive fentanyl (5 μg/ml) solution through PCA pump, programmed to deliver a basal infusion of 15 μ/h ,and bolus doses of 2 ml/dose (10 μ/dose) with a 15-minute lockout interval. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients of both genders, aged between 18 and 65 years. 2. American society of Anesthesiologists (ASA) physical status I and II. 3. Patients undergoing total laryngectomy. 1. Body mass index (BMI) more than 35 kg/m2. 2. Patients with neuromuscular diseases. 3. Patients with bleeding or coagulation disorders. 4. Patients with psychiatric disorders. 5. Presence of infection at the site of injection. 6. Presence of allergy to any of medications used in this study. 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 24/08/2023 Medical Research Ethics Committee Institutional Review Board Faculty of Medicine Mansoura University
Ethics Committee Address
Street address City Postal code Country
El Gomhouria St Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score measured by visual analogue score (VAS). 2, 4, 6, 12, 18 and 24 hours postoperatively.
Secondary Outcome Cumulative fentanyl consumption. The first 24 hours postoperatively.
Secondary Outcome Heart rate (HR) and mean arterial pressure (MAP). Basal, after skin incision, after 30 minutes, after closure of skin incision and then postoperatively at 2, 4, 6, 12, 18 and 24 hours.
Secondary Outcome Time of the first rescue analgesia. Postoperative.
Secondary Outcome Duration of surgery. Intraoperative.
Secondary Outcome Length of hospital stay. Postoperative.
Secondary Outcome Incidence of postoperative side effects (nausea, vomiting, and pruritus). Postoperative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals El Gomhouria St Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University El Gomhouria St Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Faculty of Medicine El Gomhouria St Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nourhan Mohamed Elsherbiny nourhanelsherbiny@hotmail.com +201272632726 Al Teraa St
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Nourhan M. Elsherbiny
Role Name Email Phone Street address
Public Enquiries Mohamed Nashaat Mohamed Moh_nashaat@mans.edu.eg +201092323198 El Mashaya
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Mohamed N. Mohamed
Role Name Email Phone Street address
Scientific Enquiries Mona Gad Mostafa monagad78@mans.edu.eg +201062106155 El Mashaya St
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Mona G. Mostafa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data that underlie the results reported in this article will be shared beginning 9 months following publication with investigators whose proposed use of the data has been approved by Institutional Review Board (IRB), Independent Ethics Committee (IEC) or Research Ethics Board (REB). Data will be available through contacting the following email address: nourhanelsherbiny@hotmail.com Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of study completion. Open data access through contacting the following email address: nourhanelsherbiny@hotmail.com
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