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.: PACTR201710002161189 Date of Registration: 31/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between the Effect of Dexmedetomidine versus Nalbuphine as an Adjuvant to Bupivacaine in Paravertebral Block in Breast Cancer Surger
Official scientific title Comparative Study between the Effect of Dexmedetomidine versus Nalbuphine as an Adjuvant to Bupivacaine in Paravertebral Block in Breast Cancer Surgery
Brief summary describing the background and objectives of the trial Abstract Background: Breast cancer is the commonest cancer in women worldwide. Many patients are frequently admitted to the operating theaters for mastectomies. Thoracic paravertebral block (TPVB) is increasingly used as an effective mean for post-operative pain relief. Aim of the study: To evaluate the efficacy and safety of dexmeditomedine and nalbuphine as an adjuvant to bupivacaine local anesthetic in thoracic paravertebral block in cancer breast surgeries. Patients and Methods: Sixty (60) patients included in the study of ASA ¿, ¿, III were scheduled for mastectomy. These patients were randomly allocated into three groups (20) patients each: Group PB received bupivacaine (0.3 ml/ kg) + 1 ml normal saline. Group PBD received bupivacaine (0.3 ml/kg) + dexmeditomedine 1µg/kg. Group PBN received bupivacaine ( 0.3 ml/kg) and 10 mg (1 ml) nalbuphine. Results: There was no statistically significant differences among the three groups regarding demographic data, SPO2, ETCO2, HR,SBP and DBP intraoperatively. No significant difference in HR, SBP and DBP postoperatively. Postoperative pain scores were significantly higher in group BP whether at rest or movement. The sedation was significantly higher in PBD group in the early 12 hours postoperatively. Significantly lower postoperative tramadol consumption in PBN group. significantly longer time to first analgesic request (TFR) than other groups. No complications reported in any group. Conclusion: Addition of nalbuphine 10 mg as an adjuvant to bupivacaine local anesthetic in TPVB improved quality of the block and decrease postoperative analgesic requirements than bupivacaine only group and dexmeditomedine and bupivacaine group. But, adding dexmeditomedine to bupivacaine increase the time to first analgesic request and more sedation than bupivacaine and bupivacaine and nalbuphine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied breast cancer,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2016
Actual trial start date 05/05/2016
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 17/01/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 66
Recruitment status Stopped early/ terminated
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 computer generated sealed envelope Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group PB: Bupivacaine only Bubivacaine, 0,3ml/kg + 1ml normal saline the whole study time ultrasound guided 20 Placebo
Experimental Group Group PBD: Bupivacaine + Dexmeditomedine Bupivacaine 0,3ml/kg + Dexmedetomidine 1µg/kg the whole study time paravertebral block drug injection, ultrasound guided 20
Experimental Group Group PBN: Bupivacaine +Nalbuphine Bupivacaine 0,3mg/kg + 10 mg (1ml) Nalbuphin1 whole time of the study paravertebral block drug injection, ultrasound guided 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I, II, III female 18-78 breast cancer surgery Exclusion criteria included patients undergoing bilateral breast surgery or breast reconstruction; those having contra-indications for PVB, e.g., patient refusal, infection at injection site, anticoagulant therapy, abnormal coagulation profile, or hypersensitivity to LA; patients on chronic antiemetics or chronic pain medication; pregnant patients; central neuropathy, liver or renal impairment, drug or alcohol abusers, and those with psychiatric illnesses that would interfere with perception and assessment of pain and obese patients with a body mass index (BMI) >30 kg/m2. 18 Year(s) 78 Year(s) Female
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 Fayoum University Hospital
Ethics Committee Address
Street address City Postal code Country
Fayoum University District Fayoum 63511 Egypt
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 15/05/2016 Fayoum University, Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
university district, fayoum city, fayoum governorate fayoum 63511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anelgesic consumption (tramadol) pain scores >3 . in the first 48 hours
Secondary Outcome pain scores at rest and active movement of ipsilateral arm.were recorded every 30 min for initial 2 h, and at 4, 8, 24 and 48 h from T0
Secondary Outcome , intraoperative fentanyl requirements intraoperative
Secondary Outcome Time to first analgesic request (TFR), which was defined: time from completion of the paravertebral block injection till time of first analgesic request, analgesia was provided whenever NRS was >3 or when the patient requested analgesia.
Secondary Outcome complications bradycardia, hypotension nausea/vomiting, pruritus
Secondary Outcome sedation scores were recorded every 30 min for initial 2 h, and at 4, 8, 24 and 48 h from T0
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum university Hospitals Fayoum university Fayoum 63511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Fayoum University Faoum University District Fayoum 63511 Egypt
Faculty of Medicine Fayoum University Faoum University District Fayoum 63511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Fayoum University Faoum University District Fayoum 63511 Egypt University
Primary Sponsor Faculty of Medicine Fayoum University Faoum University District Fayoum 63511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Joseph botros 105 toman bai st, Zeitoun province Cairo 11321 Egypt
Mohammad Omar Mohammad Sabry ElBekbashi st, floor 3, app 3 Fayoum 63511 Egypt
Atef Mohammad Sayed Khaleel Fayoum University District Fayoum 63511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Botros dr_jo27@yahoo.com 01227598825 105 Toman Bai street, Zeitoun, Egypt
City Postal code Country Position/Affiliation
Cairo 11321 Egypt lecturer of Anesthesiology Fayoum University
Role Name Email Phone Street address
Principal Investigator Atef Khalil dr.atef.khalil@gmail.com 01013331617 Faoum University District
City Postal code Country Position/Affiliation
Fayoum Egypt lecturer of Anesthesiology Fayoum University
Role Name Email Phone Street address
Principal Investigator Mohamad Omer drmomer89@gmail.com 01118765868- 01092895804 Mohammad Sabry ElBekbashy street, Mostaffa Saadawy House, 3rd floor, app 3
City Postal code Country Position/Affiliation
Fayoum 63511 Egypt Resident of Anesthesiology Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Joseph Botros dr_jo27@yahoo.com 01227598825 105 toman bai st, Zeitoun province
City Postal code Country Position/Affiliation
Cairo 11321 Egypt lecturer of Anesthesiology, Faculty of medicine , Fayoum university
REPORTING
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