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.: PACTR202209505436358 Date of Approval: 09/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae plane block versus low dose ketamine-dexmedetomidine intravenous infusion as opioid free analgesia for modified radical mastectomy
Official scientific title A randomized comparative study of erector spinae plane block versus low dose ketamine-dexmedetomidine intravenous infusion as intraoperative opioid free analgesia for modified radical mastectomy
Brief summary describing the background and objectives of the trial This study will be conducted to compare the analgesic efficacy of two alternative intraoperative opioid-free analgesic techniques. Erector spinae plane block and low dose ketamine-dexmedetomidine intravenous infusion are well known opioid sparing analgesic techniques with minimal side effects. The primary outcome is the total postoperative 24-hour morphine consumption while the secondary outcomes are anesthetic consumption, time to awakening, pain scores at rest and arm movement during the postoperative 24 hours, duration of analgesia, change of serum cortisol level as indicator of stress response postoperatively, and severity of postoperative nausea and vomiting. After calculation of sample size based on the data obtained from a pilot study using postoperative-24-hour morphine consumption as the primary outcome, patients will be randomly allocated into two equal groups each of 42 participants, ESPB group and Ket-dex group. After induction of general anesthesia, ESPB group will be injected by 20 ml of bupivacaine 0.5% deep to erector spinae muscle under US guidance. Meanwhile, Ket-dex group will receive an IV loading dose of ketamine 0.25 mg/Kg and dexmedetomidine 0.5 mcg/Kg followed by IV infusion of ketamine 0.25 mg/Kg/hr and dexmedetomidine 0.3 mcg/Kg/hr in separate infusion pumps. After awakening, pain score will be assessed by numerical rating scale (NRS) during rest and arm movement. When it becomes ≥4, duration of analgesia will be recorded and post-operative analgesia regimen will be started. It includes IV ketorolac 30 mg/12 hrs and 1 gm paracetamol /8 hrs. If pain score persists to be ≥4, IV morphine 0.05 mg/Kg till 4 mg maximum will be given. Any adverse events will be recorded and managed. Then data will be collected, tabulated and statistically analyzed to conclude clinically and statistically significant differences between both groups.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Acute pain management
Anticipated trial start date 10/09/2022
Actual trial start date 20/09/2022
Anticipated date of last follow up 26/04/2023
Actual Last follow-up date 27/09/2023
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 84
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R.22.07.1762 Medical Research Ethics Committee, Institutional Review Board, Mansoura Faculty of Medicine, 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Erector Spinae Plane block 20 milliliters of bupivacaine 0.5% Single shot Patients will be turned laterally on the contralateral side of the operation observed by assistant anesthesiologist. Under aseptic precautions, experienced anesthesiologist will perform the block under ultrasound (US) guidance. The spine of fifth thoracic vertebra (T5) will be identified by counting down from the spine of seventh cervical vertebra (C7). Then, a high frequency linear probe (3-15 MHz) of US machine will be placed lateral to T5 spinous process with lateral scanning searching for T5 transverse process (TP). The anechoic shadow of the transverse process with three muscles (trapezius, rhomboidus major and erector spinae muscles, from outside inwards) will be identified. An 18-gauge Quincke spinal needle will be inserted in plane in a craniocaudal direction till it contacts the TP deep to erector spinae muscle (ESM). After injection of 5 ml of normal saline 0.9% to confirm correct needle placement, 20 ml of 0.5% bupivacaine will be injected, with frequent aspiration to exclude vascular puncture, visualizing the linear hydro-dissection between ESM and anechoic shadows of TPs. Then, patients will be turned supine to be prepared for surgery. 42 Active-Treatment of Control Group
Experimental Group Low dose ketamine Dexmedetomidine Intravenous infusion IV loading dose of ketamine 0.25 mg/Kg and dexmedetomidine 0.5 mcg/Kg followed by IV infusion of ketamine 0.25 mg/Kg/hr and dexmedetomidine 0.3 mcg/Kg/hr in separate infusion pumps Throughout the duration of surgery to be stopped with start of skin closure Patients will receive an IV loading dose of ketamine 0.25 mg/Kg and dexmedetomidine 0.5 mcg/Kg followed by IV infusion of ketamine 0.25 mg/Kg/hr and dexmedetomidine 0.3 mcg/Kg/hr in separate infusion pumps into a dedicated IV cannula through a triple way connector. Infusions will be discontinued with start of skin closure 30 minutes before termination of surgery. 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Female. 2- Age group 20 – 60 years old. 3- ASA physical status I-II. 4- Scheduled for modified radical mastectomy. 1- Male. 2- Age < 20 or > 60 years old. 3- ASA physical status >II. 4- Mental illness. 5- Drug abuse. 6- Patient refusal. 7- Bilateral mastectomy or additional surgical reconstruction procedures. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Female
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 16/08/2022 Institutional review board mansoura faculty of medicine mansoura university
Ethics Committee Address
Street address City Postal code Country
Al Gumhoria Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total postoperative 24-hour morphine consumption. It is the sum of total rescue morphine boluses in milligrams given on request when NRS equals or becomes more than 4 ,after ketorolac and paracetamol, throughout the postoperative 24 hours. By the end of postoperative 24 hours
Secondary Outcome Anesthetic consumption. The total amount of isoflurane inhalational anesthetic consumption in milliliters adjusted to keep hemodynamics within twenty percent of its basal values throughout the surgery. After ex-tubation and recovery from general anesthesia.
Secondary Outcome Time to awakening. It is the time in minutes from end of surgery till spontaneous eye opening or on verbal command. At recovery when patient opens his eyes spontaneously or on verbal command
Secondary Outcome Pain scores during rest. It is pain score assessed by numerical rating scale (NRS) at rest as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness Regaining full consciousness, postoperative 2nd, 4th, 6th, 12th, 24th hours.
Secondary Outcome Pain scores during arm movement. It is pain score assessed by numerical rating scale (NRS) during arm movement as 0 for no pain till 10 for the worst pain imaginable starting from regaining full consciousness. Regaining full consciousness, postoperative 2nd, 4th, 6th, 12th, 24th hours
Secondary Outcome Duration of analgesia. It is the time in hours elapsed from administration of the analgesic medications till NRS equals or becomes more than 4. After recovery when NRS equals or becomes more than 4.
Secondary Outcome Change of serum cortisol level postoperatively. It is the serum level of cortisol in micrograms per deciliter after regaining consciousness compared to the basal levels before the start of general anesthesia. Basal levels before induction of general anesthesia and postoperative levels after regaining consciousness.
Secondary Outcome Severity of postoperative nausea and vomiting. It is nausea assessed by 4-point categorical scale (0= none, 1= mild, 2= moderate, 3= severe) depending on its frequency, intensity, duration and progression to vomiting. When vomiting occurs or nausea becomes moderate or severe, IV metoclopramide 10 mg will be given. 30-minute, 1-hour and 24-hour postoperative time points
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncology Center Mansoura University Al Gomhuria st Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Medhat Mohasseb Al Gomhuria Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Medhat mohasseb and Mohammed Nashaat Mohammed Al Gumhoria Mansoura 35511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammed Nashaat Mohammed Al Gomhuria Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohasseb a_medhat88@mans.edu.eg 201001272216 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of anesthesia and surgical intensive care faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohammed Nashaat moh_nashaat@mans.edu.eg 201092323198 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of anesthesia and surgical intensive care faculty of medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Ahmed Medhat dr.a_medhat88@hotmail.com 201551034402 Al Gomhuria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Committee
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. Study Protocol 2 years Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to a_medhat88@mans.edu.eg. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.mans.edu.eg 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