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.: PACTR201612001903142 Date of Approval: 03/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spinal nalbuphine in anorectal surgery
Official scientific title Optimal dose intrathecal nalbuphine may improve markedly the duration analgesia with low side effect profile during anorectal surgery
Brief summary describing the background and objectives of the trial There is no doubt that intrathecal opioids have been used for subarachnoid block with or without local anesthetic to allow complete analgesia during surgical procedures. However their use is limited for fear of their side effects specially respiratory depression . Morphine is the standard opioid medication used for intra and postoperative analgesia . But owing to its associated adverse effects including (respiratory depression , nausea , vomiting constipation , pruritis and urine retention) its use is limited . (1)Various agents have been searched to replace morphine . Optimization of the dose of spinal narcotics is vital to avoid unpleasant side effects. Nalbuphine which is a mixed agonist antagonist ' being kappa agonist and mu antagonist can be preferred due to less respiratory depression and vomiting than morphine . Also It can mimic morphine in its analgesic duration if used with optimal dose .Nalbuphine,on the other hand, being mu antagonist and kappa agonist ,has a ceiling effect in its respiratory depression [2,3];hence it is considered to be safer than morphine. Many studies have reported that the incidence of adverse effects like pruritus and PONV is lower with nalbuphine in comparison with morphine [4, 5]. One study concluded that the optimal dose of nalbuphie is 0.8 mg in surgery while another one concluded that it is 1.6 mg in lower limb surgery . We hypotheses that higher doses of nalbuphine can improve markedly duration of analgesia with insignificant side effect profile.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anorectal surgeries like piles , fissures , etc,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 17/02/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 28/12/2016
Actual Last follow-up date 30/11/2016
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R2/15.11.67 IRP /Mansoura faculty of medicicne
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Simple randomisation using by using procedures such as coin-tossing or dice-rolling Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Spinal nalbuphine 2 ml of bupivacaine 0.5% with nalbuphine 1 mg in a total volume of 3 ml single injection group A will receive bupivacine 10 mg mixed with nalbuphine 1 mg intrathecally at the level of L4-5 or L5 ¿S1intervertebral space after proper sterilization and patients is allowed to sit for 3 minutes for blockade of the sacral dermatomes then he was shifted to the supine position . (Total volume of 3 ml) . 22 Active-Treatment of Control Group
Experimental Group Spinal nalbuphine 2 ml of bupivacaine 0.5% with nalbuphine 2mg in a total volume of 3 ml single injection group B will receive bupivacine 10 mg mixed with nalbuphine 2 mg intrathecally at the level of L4-5 or L5 ¿S1intervertebral space after proper sterilization and patients is allowed to sit for 3 minutes for blockade of the sacral dermatomes then he was shifted to the supine position . (Total volume of 3 ml) . 22
Experimental Group Spinal nalbuphine 2 ml of bupivacaine 0.5% with nalbuphine 4mg in a total volume of 3 ml single injection group C will receive bupivacine 10 mg mixed with nalbuphine 4mg intrathecally at the level of L4-5 or L5 ¿S1intervertebral space after proper sterilization and patients is allowed to sit for 3 minutes for blockade of the sacral dermatomes then he was shifted to the supine position . (Total volume of 3 ml) . 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients ASA I and II status 2. Patients who will anorectal surgery like Hemmorrhoids, perianal fistula or tumors in the anal region will be included in this study. 3. The age group is between 20 and 70 years old. 1. Refusal of the patient. 2. Respiratory problems like chronic obstructive pulmonary disease (COPD) or asthmatic patients. 3. Previous history of increased intracranial pressure. 4. Renal or hepatic disease . 5. Coagulopathy . 6. Systemic or local Infection at the puncture site. 7. Allergy to local anesthetics. 8. ASA III and IV. 9. History of opioid administration in the last hours . 20 Year(s) 70 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 14/02/2016 IRB Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score will be assessed for all patients immediately after surgery, then 2,4 6,12,18 and 24 hours after surgery using visual analogue scale and numerical pain scor immediately after surgery, then 2, 4 6, 12, 18, 24 hours after surgery
Secondary Outcome Hemodynamics which will include mean blood pressure, heart rate and oxygen saturation will be studied during surgery every 15 minutes, Then 30 minutes and 2 hours after surgery
Secondary Outcome the time of 1st opioid requirement the time of 1st opioid requirement
Secondary Outcome side effects will be recorded including hematoma , nausea , vomiting or nerve injury . including hematoma , nausea , vomiting or nerve injury .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansourah university hospital , Mansourah university . Elgmhoria street ElMansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University hospitals Elgmhoria street ElMansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University hospitals Elgmhoria street ElMansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Khalid Elbahrawy Elgmhoria street ElMansourah 35516 Egypt
Alaa-Eldin Adel El Maadawy Elgmhoria street ElMansourah 35516 Egypt
Ahmed E. Lotfy Elgmhoria street ElMansourah 35516 Egypt
Maha A. Abo-Zeid Elgmhoria street ElMansourah 35516 Egypt
Khalid Elbahrawy Elgmhoria street ElMansourah 35516 Egypt
Alaa-Eldin Adel El Maadawy Elgmhoria street ElMansourah 35516 Egypt
Ahmed E. Lotfy Elgmhoria street ElMansourah 35516 Egypt
Maha A. Abo-Zeid Elgmhoria street ElMansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alaa eldin Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer in anesthesia , pain management
Role Name Email Phone Street address
Public Enquiries alaa eldin Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer in anesthesia , pain management
Role Name Email Phone Street address
Scientific Enquiries alaa eldin Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer in anesthesia , pain management
REPORTING
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