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.: PACTR202408626945341 Date of Approval: 06/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Opioid Sparing Analgesia of Superficial Cervical Plexus Block Versus Ketamine and Dexmedetomidine Infusion for Upper Tracheal Resection and Reconstruction
Official scientific title A Randomized Comparative Study Between Ultrasound Guided Bilateral Superficial Cervical Plexus Block Versus Intravenous Ketamine and Dexmedetomidine Infusion as Opioid Sparing Analgesia for Upper Tracheal Resection and Reconstruction Surgeries
Brief summary describing the background and objectives of the trial Avoiding any postoperative strain that could disrupt the tracheal anastomosis makes the postoperative period critical. Combined general anesthesia with either regional anesthesia or non-narcotic analgesics decreases both anesthetic and opioid consumption. Subsequently, their side effects will be decreased including agitation, cough, nausea and vomiting. The objective of this trial is to compare the efficacy of bilateral superficial cervical plexus block versus IV infusion of ketamine and dexmedetomidine as two different opioid sparing analgesic modalities for tracheal resection and reconstruction surgeries. The primary outcome is the time to first request for rescue analgesia. The secondary outcomes encompass extubation time, degree of postoperative agitation, cough, nausea and vomiting and intraoperative and postoperative heart rate and systolic blood pressure. In addition, Postoperative pain scores will be evaluated by VAS throughout the 24 hours following the surgery. Moreover, the total dose of intraoperative and postoperative fentanyl rescue analgesic consumption will be summated.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Opioid sparing modalities for perioperative anesthesia care
Anticipated trial start date 01/09/2024
Actual trial start date 15/09/2024
Anticipated date of last follow up 15/04/2025
Actual Last follow-up date 01/05/2025
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 66
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bilateral ultrasound guided superficial cervical plexus block 10 ml bupivacaine 0.5% on each side Once intraoperatively Under guidance of ultrasound machine (PHILIPS CLEAR VUE 350), the block technique will be performed by an anesthetist not involved in the study protocol after induction of anesthesia and before start of surgery. In supine position with the head turned to the contralateral side and under complete aseptic condition, the linear ultrasound transducer (L12-4, Active Array), with directional marker medially, will be placed across the anterior of the neck and slipped laterally with a transverse orientation at the level of the midpoint of the line connecting the mastoid process with the insertion of the sternal head of sternocleidomastoid muscle (SCM). When the cords of the superficial cervical plexus are visualized as a small collection of hypo-echoic nodules deep to the posterolateral border of the SCM and superficial to the prevertebral fascia just above the levator scapulae muscle, a 22 gauge Quincke needle will be inserted in plane at the posterior border of SCM. Needle advancement will be continued underneath sternocleidomastoid belly from lateral to medial toward the cords of the plexus. The needle tip position will be confirmed by injecting 5 ml 0.9% normal saline and visualizing the hydro-dissection. Then, after negative aspiration, 10 ml bupivacaine 0.5% will be injected. 33 Active-Treatment of Control Group
Experimental Group Intravenous ketamine and dexmedetomidine infusion Gradual IV loading dose of 0.25 mg/kg of ketamine and 0.5µg/kg of dexmedetomidine, followed by an IV infusion of 0.25 mg/kg/h of ketamine and 0.3 µg/kg/h of dexmedetomidine via two syringe pumps Throughout the duration of surgery After insertion of a second intravenous cannula, gradual IV loading dose of 0.25 mg/kg of ketamine and 0.5µg/kg of dexmedetomidine, followed by an IV infusion of 0.25 mg/kg of ketamine and 0.3 µg/kg of dexmedetomidine per hour via two syringe pumps. 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Enrolled for TRR surgery. ASA I and II Either sex Aged between 18 and 40 years old Patients’ refusal to participate in the study. Patients with local infection at injection site. Coagulopathy. ASA >II. Pregnancy. Un-cooperation with the study protocol and pain scale assessment. Mental retardation. Drug addiction. Known history of allergy to the study drugs. Adult: 19 Year-44 Year 18 Year(s) 40 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 09/01/2024 Institutional review board
Ethics Committee Address
Street address City Postal code Country
Al-gumhuria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to first request for rescue analgesia Once postoperative visual analogue score for pain assessment becomes four or more
Secondary Outcome Extubation time From discontinuation of inhalational anesthesia to Extubation
Secondary Outcome Degree of postoperative agitation After emergence from general anesthesia in PACU
Secondary Outcome Cough After emergence from general anesthesia in PACU
Secondary Outcome Postoperative nausea and vomiting After emergence from general anesthesia in PACU
Secondary Outcome Heart rate and systolic blood pressure Every 15 minutes intraoperatively then averaged for one hour and during the first and second postoperative hours
Secondary Outcome Postoperative pain scores first, fourth, sixth, eighth, 12th and 24th postoperative hours
Secondary Outcome The total dose of intraoperative and postoperative fentanyl rescue analgesic consumption After 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Al-gumhuria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Al-gumhuria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Al-gumhuria street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Nashaat Moh_nashaat@mans.edu.eg 01092323198 Al Gomhuria st.
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohasseb a_medhat88@mans.edu.eg 01001272216 Al Gomhuria st.
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Reem Elsharkawy reemraouf64@gmail.com 01006151100 Al Gomhuria st.
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices will be available after 3 months till 5 years following article publication by researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website. Informed Consent Form,Statistical Analysis Plan,Study Protocol After 3 months till 5 years following article publication Data requestors will need to sign a data access agreement.
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