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.: PACTR201805003370384 Date of Approval: 04/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Naloxone as an adjuvant to bupivacaine in intrapleural infiltration
Official scientific title Small dose of naloxone as an adjuvant to bupivacaine in intrapleural infiltration after thoracotomy surgery; prospective, control study
Brief summary describing the background and objectives of the trial Postoperative pain plays a significant role in the pathogenesis of postoperative pulmonary complication especially after upper abdominal and thoracic operations. Diminishing lung volumes due to acute restrictive pulmonary dysfunction secondary to pain may result in relative hypoxaemia, major atelectasis and pulmonary consolidation.Thoracotomy has been reported to produce one of the most intense postoperative pain experiences known and successful control of pain after thoracotomy is still an unresolved problem.Ultra-low dose of naloxone have been shown to release endorphins and also displace endorphins from receptor site.8 Animal experiments have shown the safety of intrathecal naloxone administration but not used before with bupivacaine intrapleural in pediatric.Intrapleural regional analgesia .This technique may provide a unique form of regional analgesia that has proven advantageous for upper abdominal surgical interventions.Aim of this study is to evaluate the efficacy of naloxone as an adjuvant to bupivacaine on post thoracotomy pain control in adult. Our primary outcome will be the time for the first request for rescue analgesia, while the secondary outcome includes the severity of postoperative pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain after thoracotomy,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/05/2018
Actual trial start date
Anticipated date of last follow up 04/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group bupivacaine- naloxone group A 30 ml of bupivacaine 0.5% with 100 ng of naloxone A 30 ml of bupivacaine 0.5% with 100 ng of naloxone will be injected over 5 min with clamping of chest tube for 15 min.once only At the end of surgery and the beginning of skin closure, the surgeon inserted a 20 G catheter between the visceral and parietal pleurae and 30 ml of bupivacaine 0.5% with 100 ng of naloxone over 5 min with clamping of chest tube for 15 min. 30 Active-Treatment of Control Group
Control Group bupivacaine group A 30 ml of bupivacaine 0.5% will be injected A 30 ml of bupivacaine 0.5% will be injected over 5 min with clamping of chest tube for 15 min. once At the end of surgery and the beginning of skin closure, the surgeon inserted a 20 G catheter between the visceral and parietal pleurae and 30 ml of bupivacaine 0.5% over 5 min with clamping of chest tube for 15 min. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 patients of either sex, ASA I &II, 18-60 years, scheduled to undergoing unilateral thoracic surgery (diaphragmatic hernia repair, lymph node excision, decortication and pneumonectomy) Emergency operations, previous thoracotomy, allergy to local anesthetics (LAs), previous unusual response or complications related to anesthesia, pre-existing coagulopathy, sever comorbidity, patients with a history of pleuritis, history of traumatic or spontaneous pneumothorax, haemothorax, or pneumonia or another condition responsible for a potential increase in absorption of local anaesthetic, cardiac failure, known upper airway obstruction or apnoeic attacks and local infection 18 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 25/04/2018 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 the time for the first request for rescue analgesia within the first 24 hours after surgery
Secondary Outcome the severity of postoperative pain A pain score will be determined before treatment, at 15 min intervals in the first hour of treatment and then at 6, 12, 18, and 24 h after the first injected LA dose
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@yahoo.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 assistant lecturer of phonetics
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 professor of anesthesia and surgical intensive care unit
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