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.: PACTR201611001848252 Date of Approval: 03/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospective randomaized study of interscalene brachial plexus block using 0.5% bupivacaine Hcl with or without dexamethasone in shoulder surgery
Official scientific title Prospective randomaized study of interscalene brachial plexus block using 0.5% bupivacaine Hcl with or without dexamethasone in shoulder surgery
Brief summary describing the background and objectives of the trial Interscalene brachial plexus block (ISBPB) is one of the most commonly used techniques for regional anesthesia of the upper limbs. With US-guided interscalene block requires lower LA doses, and the reduction in anesthetic volume for ISBPB resulting in anesthesia of the upper limb, adequate postoperative analgesia, and minimal influence on diaphragmatic block.The use of perineural dexamethasone prolongS analgesic duration of peripheral nerve blocks with variable results. Primary Objectives: 1. To determine the duration of analgesia (time to first analgesic request) after interscalene blocks when dexamethasone is added to bupivacaine for patients undergoing painful shoulder surgeries 2. To evaluate any difference in postoperative pain scores after interscalene block due to adding dexamethasone. Secondary Objectives 1. To evaluate the effect of low volume of bupivcaine versus high volume adding on postoperative pain. 2. To determine any increase in incidence of complications of interscalene blocks due to high versus low volume of bupivcaine and with adding dexamethasone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,shoulder surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/05/2016
Actual trial start date 15/06/2016
Anticipated date of last follow up 11/10/2016
Actual Last follow-up date 20/10/2016
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL not yet
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group C patients will receive 4ml of bupivacaine HCL 0.5% +1 ml of dexamethasone(4 mg ). For 36 hours postoperative Sensation of the upper extremity reported by pinprick testing from C4 to T1 dermatomes and scored as full sensation=1 and loss of sensation to touch or pinprick=0 The motor power assessment of the deltoid, biceps, triceps, finger flexion (median), finger extension (radial), and finger abduction (ulnar) Visual analogue scale for pain assessment The duration of the analgesia 25
Experimental Group group A patients will receive 10ml of bupivacaine HCL 0.5%. For 36 hours postoperative Sensation of the upper extremity reported by pinprick testing from C4 to T1 dermatomes and scored as full sensation=1 and loss of sensation to touch or pinprick=0 The motor power assessment of the deltoid, biceps, triceps, finger flexion (median), finger extension (radial), and finger abduction (ulnar)Visual analogue scale for pain assessment The duration of the analgesia 25
Experimental Group group B patients will receive 5ml of bupivacaine HCL 0.5%. For 36 hours postoperative Sensation of the upper extremity reported by pinprick testing from C4 to T1 dermatomes and scored as full sensation=1 and loss of sensation to touch or pinprick=0The motor power assessment of the deltoid, biceps, triceps, finger flexion (median), finger extension (radial), and finger abduction (ulnar) Visual analogue scale for pain assessment The duration of the analgesia 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age ¿18 and ¿ 70 yr, ASA I¿II, BMI < 35 patient refusal contraindication to interscalene block (severe chronic obstructive pulmonary disease, infection, coagulopathy, contralateral diaphragmatic paralysis) pregnancy neuropathy of the surgical limb recent (less than six months) use of glucocorticoids for at least two weeks chronic pain requiring daily use of opioid medication (greater than 30 mg/day of oral oxycodone equivalent). 18 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 21/03/2016 Alexandria University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ramal station alexandria 000000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To determine the duration of analgesia (time to first analgesic request) after interscalene blocks when dexamethasone is added to bupivacaine for patients undergoing painful shoulder surgeries 2. To evaluate any difference in postoperative pain scores after interscalene block due to adding dexamethasone. the timing of first analgesia requisite and the dose of postoperative rescue analgesia was recorded. Visual analogue scale for pain assessment was done 30 minute after entry to the recovery room and repeated every 2 hours for 6 hours, then every 6 hours for 36 hours.
Secondary Outcome 1. To evaluate the effect of low volume of bupivcaine versus high volume adding on postoperative pain. 2. To determine any increase in incidence of complications of interscalene blocks due to high versus low volume of bupivcaine and with adding dexamethasone. Complications of the block were assessed: Dyspnea, Hoarseness of voice, Horner¿s syndrome, Bezold-jarish reflex. A single observer (research associate) blinded to group allocation was responsible for all the data collection.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospital. ramal station alexandria 000000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria university ramal station alexandria 000000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria university ramal station alexandria 000000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rehab Abd El Raof Abd El Aziz alex university alexandria 000000 Egypt
Rabab Saber Saleh alex university alexandria 000000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab Zayed trcium2002@yahoo.com 01001073703 alexandria
City Postal code Country Position/Affiliation
alexandria 000000 Egypt Lecturerof Anesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Egypt
Role Name Email Phone Street address
Public Enquiries Rehab Zayed trcium2002@yahoo.com 01001073703 alexandria
City Postal code Country Position/Affiliation
alexandria 000000 Egypt Lecturerof Anesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Egypt
Role Name Email Phone Street address
Scientific Enquiries rabab saleh roba98@hotmail.com 01223497339 alexandria
City Postal code Country Position/Affiliation
alexandria 000000 Egypt Lecturerof Anesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Egypt
REPORTING
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