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.: PACTR201707002412282 Date of Approval: 07/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Levobupivacine versus levobupivacine dexmedetomidine in thoracic paravertebral block for laparoscopic sympathectomy
Official scientific title Levobupivacine versus levobupivacine dexmedetomidine in thoracic paravertebral block for laparoscopic sympathectomy
Brief summary describing the background and objectives of the trial Pain after sympathectomy is considerable and restriction of chest movement is frequently observed. Successful acute postoperative pain management remains challenging and if not adequately controlled may increase the likelihood of subsequent chronic pain in the operative area, movement restriction and post operative nausea and vomiting (PONV) (luoma et al., 2005) (Hache et al., 2009). General anesthesia cannot provide postoperative incisional pain control, also general anesthesia (with exception of large doses of opioid) do not eliminate the surgical stress response, aggravate immunosuppresion and may cause undesirable side effects such as nausea and vomiting (Rüsch et al., 2010) ,the routine use of parenteral narcotics in these cases further aggravate the situation. Recovery time is prolonged and hospital stay is lengthened with more hospital costs (Liu et al., 2005).In light of this situation, various regional anesthetic techniques for thoracic surgery have been suggested including field block, local anesthetic infiltration, intercostal nerve block, epidural anesthesia, paravertebral block and brachial plexus block (Klein et al., 2004). Thoracic paravertebral nerve block (TPVB) can provide high quality analgesia which can be used for patients undergoing many types of surgery, and also for those suffering from trauma pain and chronic pain. Although most clinical reports and research relate to unilateral TPVB, a diversity of publications challenges the assumption that it cannot be applied to midline surgery. Bilateral PVB has been successfully used in the thoracic, abdominal, and pelvic regions. Many drugs had been used as an adjuvant to local anesthetics in paravertebral block such as dexmedetomidine (precedex). It has a local anesthetic like properties. Moreover , It acts by inhibitory neuronal actions on alpha 2 adrenoceptor decreasing sympathetic tone with attenuation of neuroendocraine and hemodynamic responses to anesthesia and surgery .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,palmer hyperhydrosis,Skin and Connective Tissue Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2016
Actual trial start date 20/05/2016
Anticipated date of last follow up 30/12/2016
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura University. Institutional review board (IRB) of anesthesia and surgical Intensive care department - Mansoura Uni
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group L: Levobupivacaine group isobaric 0.5% bupivacaine 1 mg/ kg in 20 ml single shot Group L: Levobupivacaine group Patient will receive isobaric 0.5% bupivacaine 1 mg/ kg in 20 ml volume. 17 Active-Treatment of Control Group
Experimental Group Group LD: Levobupivacaine with dexmedetomidine isobaric bupivacaine 0.5% in a dose of 1 mg / kg and 10 µg dexmedetomidine in 20 ml volume. single shot Group LD: Levobupivacaine with dexmedetomidine group Patient will receive isobaric 0.5% bupivacaine 1 mg / kg and 10 µg dexmedetomidine in 20 ml volume. 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients (ASA I-II- III) aged 20-45 years submitted for unilateral laparoscopic thoracic sympathectomy due to palmer hyperhydrosis Major systemic disease, chronic chest disease , chronic pain disorders, drug abuse, allergy to any medication included in the study protocol, any psychiatric disorder, coagulation or bleeding disorders, any contraindication to general anesthesia. 20 Year(s) 45 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 06/06/2016 (IRB) of anesthesia and surgical Intensive care department - Mansoura University.
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the postoperative pain by visual analogue pain score. VAS 30 min postop VAS 1 hr postop VAS 3 hrs postop VAS 6 hrs postop VAS 12 hrs postop VAS 24 hrs
Secondary Outcome the timing of first rescue analgesia postoperatively
Secondary Outcome total opioid consumption of fentanyl in 24 hours postoperatively in 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals 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 University
COLLABORATORS
Name Street address City Postal code Country
Doaa Diab Elgmhoria street Elmansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa elmaddawy aaae72@gmail.com 0020114226976 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
elmansourah Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Alaa elmaddawy aaae72@gmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
elmansourah Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Alaa elmaddawy aaae72@gmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
elmansourah Egypt Lecturer
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