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.: PACTR202007664590852 Date of Approval: 08/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intrathecal Versus Intravenous Tramadol in prevention of Post-spinal anaesthesia Shivering
Official scientific title Intrathecal Versus Intravenous Tramadol in prevention of Post-spinal anaesthesia Shivering
Brief summary describing the background and objectives of the trial Spinal anesthesia (SA) is a very common technique used by anesthesiologist (1). It involves the injection of a local anaethetic into the subarachnoid space to anaesthetize the lower part of the body. Shivering is a common complication following SA. The incidence varies from 40% to 70%.[1] It is a spontaneous, involuntary and oscillatory fasciculations, or tremor-like hyperactivity of the skeletal muscles.[2] This makes it distressing for both the patient and the surgeon. It increases metabolic rate, oxygen consumption, CO2 production, heart rate, and blood pressure.[1,2] These increase the cardiac workload leading to wound pain, delay wound healing, and prolong hospital stay. It also interferes with the perioperative vital monitoring and increases intraocular and intracranial pressures.[1] All these sequelae coupled with the high incidence of postopearative shivering makes its prophylaxis imperative. Prophylaxis with intravenous (IV) tramadol produces a dose-dependent reduction in the incidence of postanesthesia shivering.[3] Tramadol is a commonly used intrathecal (IT) adjuvant. It prolongs the duration of sensory and motor block, and improves postoperative analgesia. Few studies assess antishivering efficacy of IT tramadol .[2] So the present study aims to compare the antishivering effect of both routes of tramadol (IT and IV) in patients undergoing lower limb orthopedic surgeries under SA. references:1. De Witte J, et al. Perioperative shivering:Physiology and pharmacology.Anesthesiology.2002;96:467–84 2. Prasad RB, et al. Effectiveness of addition of intrathecal tramadol with hyperbaric bupivacaine in prevention of shivering in parturients undergoing caesarean section under spinal anaesthesia: A randomized placebo-controlled study. Karnataka Anaesth J. 2015;1:123–7. 3. Mohta M, et al. Tramadol for prevention of postanaesthetic shivering: A randomised double-blind comparison with pethidine. Anaesthesia. 2009;64:141–6.
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 Prevention
Anticipated trial start date 01/07/2020
Actual trial start date 09/08/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 06/01/2021
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
Recruitment status Completed
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 IV tramadol 3ml (15mg) of hyperbaric bupivacaine 0.5% intrathecally and intravenous tramadol 0,25mg/kg (20-25mg) at the beginning of anaesthesia. then 25mg IV tramadol everytime shivering occurs intraoperatively After obtaining approval of the Hospital ethics committee, data collection will be started. I- Preoperative visit: 1- Explanation of the procedure of Anaesthesia. 2- A written informed consent from the patients. 3- Inform the patient that fasting hours will be about 6 to 8 hours for food and particulate fluid and 2 hour for clear fluid before the surgery. 4- Reassurance of the patient. II- Preoperative assessment: A) Medical history: B) Physical examination: C) Anesthetic assessment: •Airway assessment •Examination of the limbs for predication of difficult cannulation. • Examination of the spine to predict difficult spinal anesthesia. D) Laboratory investigations& imaging: Complete blood count, Prothrombin time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR) and other investigations according to the patient condition Chest x-ray for smoker and asthmatic, electrocardiogram (ECG) for hypertensive patients, kidney function test or liver function test for renal or hepatic patients respectively. II-Anesthetic Management: Pre-anaethetic period: • The anesthetic room temperature will be adjusted to be around 22 Celsius. • Standard intraoperative monitoring with electrocardiogram (ECG), non-invasive arterial blood pressure, pulse oximetry and Temp probe will be used. • A peripheral venous cannula will be inserted. • All patients will start to receive warmed 500 ml of ringer's acetate as co-load. Administration of Anesthesia: The patient will be placed in a sitting position, sterilization of the back by betadine, local anesthetic infiltration in skin and a 25 gauge Quincke needle will be placed at the L2/3, L3/4 or L4/5 interspaces) using para-median approach. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid. 43 Active-Treatment of Control Group
Experimental Group intrathecal tramadol intrathecal 3 ml (15mg) of hyperbaric bupivacaine 0.5% with 20 mg of tramadol once at the beginning of anaethesia. then 25mg IV tramadol everytime shivering occurs intraoperatively. at the beginning of anaethesia. then 25mg IV tramadol everytime shivering occurs intraoperatively. After obtaining approval of the Hospital ethics committee, data collection will be started. I- Preoperative visit: 1- Explanation of the procedure of Anaesthesia. 2- A written informed consent from the patients. 3- Inform the patient that fasting hours will be about 6 to 8 hours for food and particulate fluid and 2 hour for clear fluid before the surgery. 4- Reassurance of the patient. II- Preoperative assessment: A) Medical history: B) Physical examination: C) Anesthetic assessment: •Airway assessment. •Examination of the limbs for predication of difficult cannulation. • Examination of the spine to predict difficult spinal anesthesia. D) Laboratory investigations& imaging: Complete blood count, Prothrombin time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR) and other investigations according to the patient condition Chest x-ray for smoker and asthmatic, electrocardiogram (ECG) for hypertensive patients, kidney function test or liver function test for renal or hepatic patients respectively. II-Anesthetic Management: Pre-anaethetic period: • The anesthetic room temperature will be adjusted to be around 22 Celsius. • Standard intraoperative monitoring with electrocardiogram (ECG), non-invasive arterial blood pressure, pulse oximetry and Temp probe will be used. • A peripheral venous cannula will be inserted. • All patients will start to receive warmed 500 ml of ringer's acetate as co-load. Administration of Anesthesia: The patient will be placed in a sitting position, sterilization of the back by betadine, local anesthetic infiltration in skin and a 25 gauge Quincke needle will be placed at the L2/3, L3/4 or L4/5 interspaces) using para-median approach. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Age 19 – 60 years old o American society of anesthesia physiological status (ASA) I and II. o All lower limb surgeries under spinal anesthesia lasting not more than 2 hours. o Both male and female gender. o Contraindication to neuro-axial block as patient refusal, infection at site of injection, bleeding disorders, neuropsychiatric disorders, sepsis, hypotension. o Allergy to opioids or local anesthetics. o Chronic opioid use or other drugs that alter pain perception. o Failure of spinal anesthesia requiring general anesthesia. o Patients of BMI >35 o Intraoperative blood loss > 30% of blood volume. o Spinal deformities. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 60 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 21/01/2020 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road, Ismailia, Egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compare the prevalence of intra-operative shivering in both groups (intrathecal tramadol and intravenous tramadol) after spinal anesthesia. continuous observation of the occurrence of shivering allover the time of surgery
Secondary Outcome • Intra-operative hemodynamics., HR,BP, temperature intraoperatively every 15 minutes till the end of surgery.
Secondary Outcome postoperative shivering, its timing, duration and score 24hrs postoperative
Secondary Outcome postoperative analgesic requirement within 24 hrs postoperatively
Secondary Outcome postoperative hemodynamics 0.5, 1, 2, 4, 6, 8, 12, 18 and 24 hrs postoperatively
Secondary Outcome time, duration and score of intraoperative shivering every time intraoperative shivering occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals Kilo 4.5, Ring road Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Kilo 4.5, Ring Road ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospitals Kilo 4.5, Ring Road ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Eman Mohmed Abd El Azeem Kilo 4.5, Ring road ismailia 41522 Egypt
Shimaa Ahmed Hamed Al Touny shebeen elkoom st. building No. 1 Ismailia 41522 Egypt
Mohamed Emad El Din Abdel Ghaffar Kilo 4.5, Ring road Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Abd El Azeem emz6622@gmail.com 00201090336016 Kilo 4.5, Ring road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt resident of anethesia and ICU
Role Name Email Phone Street address
Public Enquiries Mohamed Abdel Ghaffar mohamed_abdelghafa@med.suez.edu.eg 01003179831 Kilo 4.5, Ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt proffessor and head of department of anethesia and ICU
Role Name Email Phone Street address
Scientific Enquiries shimaa Al Touny shimaa_touny@yahoo.com 00201004042654 sheben elkoom st., building No.1
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt lecturer of anethesia and ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication I Informed Consent Form,Statistical Analysis Plan,Study Protocol beginning 9 months and ending 36 months following article publication for investigators whose proposed use of the data has been approved by an independent review committee. for individual participant data meta-analysis. proposal may be submitted up to 36 months following publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/05/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/05/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information