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.: PACTR201711002746214 Date of Approval: 03/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intrathecal morphine preemptive vs postsurgical in spine surgery
Official scientific title Effect of intrathecal morphine before and after laminectomy on intraoperative surgical stress response and postoperative pain; prospective randomized study
Brief summary describing the background and objectives of the trial Effective pain management is an important component of postsurgical care. Preoperative use of narcotics for pain management and soft tissue dissection in posterior spine surgery lead to significant postoperative pain control. Increased demand for spine surgery, and emphasis on patient-centred care and reduced length of stay in hospital, has led to a search for better methods of postoperative pain management. Regional anesthesia prevents a predominant part of the endocrine- metabolic response to surgery. This inhibitory effect of neurogenic blockade on the surgically induced endocrine-metabolic changes is most consistent during lower abdominal surgery and operations on the lower extremities. Intrathecal opioids (ITOs) are produce ¿segmental analgesia¿ resulting in localized nociception without sensory, motor, autonomic, or systemic side effects. They not only allow postoperative neurological assessment in immediate postoperative period but also avoid risk of orthostatic hypotension or motor incoordination that local anesthetics cause
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain in patients undergoing lumber laminectomy Surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/11/2017
Actual trial start date
Anticipated date of last follow up 03/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general aneasthesia Patients in this group received standard general anesthesia as other two groups from induction of aneasthesia till end of surgery Patients in this group received standard general anesthesia as other two groups 30 Active-Treatment of Control Group
Experimental Group preoperative intrathecal morphine A 2ml solution containing 0.4 mg preservative-free morphine after induction of GA.before surgery A 2ml solution containing 0.4 mg preservative-free morphine will be injected Intathecal immediately after induction of GA.before surgery 30 Active-Treatment of Control Group
Experimental Group post surgical intrathecal morphine identical solution 2ml solution containing 0.4 mg of preservative-free morphine after end of surgical procedure before recovery from aneasthsia At the conclusion of the operative procedure and before closure, the surgeon administered an identical solution 2ml solution containing 0.4 mg of preservative-free morphine 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
90 patients, American Society of Anesthesiologists (ASA) Grade I and II aged 18-65 years of either sex undergoing elective laminectomy surgery. Patients with known allergies to morphine or other opioids, patients with a history of severe respiratory illness including chronic obstructive pulmonary disease, asthma, obstructive sleep apnea, psychiatric disorders, and pregnancy, patients on sustained release narcotics and substance abuse, and patients not giving consent will be excluded from the study. 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 25/10/2017 research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tant,algharbia governate, egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome severity postoperative pain from end of surgery till 24 hrs surgery
Secondary Outcome intraoperative surgical stress response from end of surgery till 24 hrs surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 1, algeish st, tanta,algharbia governate, egypt Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany Faheem Abd El Salam Omara el estad street tanta,algharbia governate, egypt tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Amer asmaafawzyamer@yhoo.com 01002772409 3 mohamed faried st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Public Enquiries nada Omara Dr.nada.emera@gmail.com 01118342012 12 nor l din st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 01155338808 moheb st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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