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.: PACTR201709002599279 Date of Approval: 08/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Naloxone As an Adjuvant To Fenanyl-Bupivacaine in Thoracic Paravertebral Block Analgesia
Official scientific title Role Of ultra-low dose of naloxone As an Adjuvant To Fenanyl-Bupivacaine in Thoracic Paravertebral Block Analgesia after modified radical mastectomy
Brief summary describing the background and objectives of the trial Breast cancer is the most common cancer among women and most of them require breast surgery. [1] Surgery is associated with nausea vomiting, postoperative pain and chronic pain. Acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain after breast surgery. [2] Therefore, effective postoperative pain management after breast cancer surgery is necessary. Effective analgesia reduces perioperative morbidity, shortens hospitalization times, improves patient satisfaction, and lowers cost When fentanyl was used as adjuvant to local anesthetic, it improved the quality of block and prolonged the duration of postoperative analgesia, without increasing the side effects. When fentanyl was used as adjuvant to local anesthetic, it improved the quality of block and prolonged the duration of postoperative analgesia, without increasing the side effects. It has been reported that opioid receptors are expressed by central and peripheral neurons especially within injured tissues and can attenuate the excitability of primary afferent neurons and lead to anti-nociceptive effects [17]. The study of the paradoxical effects of ultra- low-dose naloxone or naltrexone started over 20 years ago, with the initial finding that while opioid agonists normally inhibit, or shorten, the action potential duration of dorsal root ganglion cells, lower doses of opioid agonists induce an opposite, excitatory effect: a prolongation of the action potential. [18,19] Ultra-low-dose (pg¿gg/kg) of naloxone combined with opioid agonists can improve their analgesic efficacy [20] via blocking the excitatory opioid receptor pathway and enhancing opioid analgesia [21,22,23] but not used before with fentanyl as adjuvants to the local anesthetic in paravertebral anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Surgery,Thoracic Paravertebral Block Analgesia after modified radical mastectomy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2017
Actual trial start date 25/10/2017
Anticipated date of last follow up 30/09/2018
Actual Last follow-up date 19/09/2018
Anticipated target sample size (number of participants) 135
Actual target sample size (number of participants) 135
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
Control Group bupavacaine group 0.3 ml/kg of 0.25% bupivacaine 15 minute before induction of anesthesia After securing the catheter in place and establishing negative aspiration, 0.3 ml/kg of 0.25% bupivacaine about 15 minute before induction of anesthesia 45 Active-Treatment of Control Group
Experimental Group fentanyl group 0.3 ml/kg of 0.25% bupivacaine and fentanyl 50 ug 15 minute before induction of anaesthesia. After securing the catheter in place and establishing negative aspiration, 0.3 ml/kg of 0.25% bupivacaine and fentanyl 50 ug about 15 minute before induction of anaesthesia.. 45 Active-Treatment of Control Group
Experimental Group naloxon group 0.3 ml/kg of 0.25% bupivacaine and fentanyl 50 ug mixed with naloxone 100ng about 15 minute before induction of anesthesia. After securing the catheter in place and establishing negative aspiration, 0.3 ml/kg of 0.25% bupivacaine and fentanyl 50 ug mixed with naloxone 100ng about 15 minute before induction of anesthesia. 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
135 patients, ASA I &II, age 40-60 years, from both sex scheduled to undergoing unilateral modified radical mastectomy ¿ Patients with known allergy to amide type local anesthetics ¿ Patients receiving non-steroidal anti-inflammatory drugs ¿ Schizophrenia or other psychotic disorder or cognitive impairment ¿ History of drug dependency or substance addiction ¿ BMI <18.5 or >30 kg m2 ¿ coagulation disorders ¿ local skin infection at the side of injection, spinal metastasis 40 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 27/09/2017 ¿ research ethics committee, quality assurance unit¿ research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain At discharge post-operative and every 2 hr postoperative till 12hr then every 6 hr for the first 24 hr .
Secondary Outcome Depth of anaesthesia will be recorded at baseline (after induction of anesthesia) and every 30 minute till the end of the 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 el bahr street . tanta tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor oncology surgery dearment ¿ 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt Hospital
Primary Sponsor tanta university hospital ¿ 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Motaz Mohamed Amr Abusabaa elmahalla, algharbia governate, egypt elmahalla 31961 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany omara amanyfaheem2011@yahoo.com 01008372249 el estad street. tanta
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 street, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tana 31511 Egypt
REPORTING
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