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.: PACTR201907766143535 Date of Approval: 05/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ketorolac as an additive to bupivacaine in pectoral nerve block
Official scientific title Ketorolac as an adjuvant to bupivacaine in ultrasound guided pectoral nerve block (I+II) for patients undergoing modified radical mastectomy under general anaesthesia
Brief summary describing the background and objectives of the trial Breast cancer is the most common cancer among women, modified radical mastectomy (MRM) is one of the optional surgical treatment of breast cancer. About 40 % of women have severe acute postoperative pain after MRM which is potentially disrupting the quality of postoperative recovery. Pectoral nerve block (PECS) is a safe and efficient peripheral nerve block that has been described recently. It allows intraoperative and postoperative analgesia for patients undergoing mastectomy. Additives to local anaesthetics improve the block efficacy and prolong its duration. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that provides analgesia by inhibiting prostaglandin synthesis. Parenteral and oral ketorolac become a popular alternative to opioids for postoperative pain. A systematic review on the use of local NSAIDs for non-ophthalmologic postoperative pain management concluded that Local NSAIDs provide analgesia in the postoperative period, it may reduce the amount of systemic NSAID and/or opioid analgesia used and adverse effects associated with local NSAID use are minimal and transient. So the aim of the study is to assess the efficacy of ketorolac as an additive to bupivacaine in pectoral nerve block (I+II) for management of postoperative pain in patients undergoing modified Radical mastectomy under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PECS
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/06/2019
Actual trial start date 25/06/2019
Anticipated date of last follow up 25/08/2019
Actual Last follow-up date 27/08/2019
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Completed
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 randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ketorolac as an additive to bupivacaine in pectoral nerve block 30 ml bupivacaine 0.25% including 30 mg ketorolac The block will be given once after induction of general anaesthesia and before skin incision. Written informed patient consent with be obtained after explanation of the procedure,its effect and complication. - Induction of general anesthesia for all participating patients with 2 μg/kg fentanyl, 1.5 - 2 mg/kg propofol and endotracheal intubation will be facilitated by 0.15 mg/kg cis-atracurium. - The Pecs block will be performed using a 2 needle approach while the patients in the supine position with the ipsilateral upper limb abducted 90 degree. - A 80 mm 21 G needle will be used with guidance of a linear array ultrasound probe of high frequency. - The probe will start from the lateral third of the clavicle and moving distally and laterally to the mid axillary line. - The first needle will be inserted in plane with ultrasound probe to the fascial plane between 2 pectoralis muscles and 10 mL of prepared volume will be injected between the 2 pectoral muscles, - The ultrasound probe will move towards axilla until the serratus anterior identified above the second, third, and fourth ribs and the second needle will be inserted into the fascial plane between pectoralis minor and serratus anterior muscles and injection of 20 mL of prepared volume. - Skin incision will be allowed 20 minutes after giving the block 23
Control Group pecs block by bupivacaine only 30 ml bupivacaine 0.25% The block will be given once after induction of general anaesthesia and before skin incision. - Written informed patient consent with be obtained after explanation of the procedure,its effect and complication. - Induction of general anesthesia for all participating patients with 2 μg/kg fentanyl, 1.5 - 2 mg/kg propofol and endotracheal intubation will be facilitated by 0.15 mg/kg cis-atracurium. - The Pecs block will be performed using a 2 needle approach while the patients in the supine position with the ipsilateral upper limb abducted 90 degree. - A 80 mm 21 G needle will be used with guidance of a linear array ultrasound probe of high frequency. - The probe will start from the lateral third of the clavicle and moving distally and laterally to the mid axillary line. - The first needle will be inserted in plane with ultrasound probe to the fascial plane between 2 pectoralis muscles and 10 mL of prepared volume will be injected between the 2 pectoral muscles, - The ultrasound probe will move towards axilla until the serratus anterior identified above the second, third, and fourth ribs and the second needle will be inserted into the fascial plane between pectoralis minor and serratus anterior muscles and injection of 20 mL of prepared volume. - Skin incision will be allowed 20 minutes after giving the block 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Females aged between 21 – 60 years • Patients ASA class II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations). • Patients with Body Mass Index (BMI) ≤ 35. • Patients with history of bleeding diathesis or on anticoagulant. • Patients with relevant drug allergy. • Prior surgery in the supraclavicular, infraclavicularor axillary regions. • Patients with psychiatric illnesses, opioid dependence; alcohol or drug abuse that would interfere with perception and assessment of pain. • Patients with any metastasis. • Deformities of (face, teeth,tongue,palate,mandible,neck) that interfere with airway management. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 60 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 16/05/2018 Suez Canal University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Ethics Committee, Faculty of Medicine, Suez Canal University, Ring road, ismailia, Egypt. Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the first time of analgesic requirement in both groups. started from extubation till 24 hours postoperatively
Secondary Outcome intra-operative hemodynamics throughout the surgery
Secondary Outcome intraoperative analgesic consumption throughout the surgery
Primary Outcome postoperative total dose of analgesic consumption 24 hrs postoperatively
Primary Outcome postoperative hemodynamics and visual analogue score 24 hrs postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University hospitals Ring road kilo 4.5, Ismailia, Egypt Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Suez Canal university Kilo 4.5, Ring road Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University hospitals Ring road kilo 4.5, Ismailia, Egypt Ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amira Gamal Abd Elnasser Mahmoud Abou Horayra st. 5000 unit, building no. 124, dapartment No. 18 Portsaid 42511 Egypt
Shimaa Ahmed Hamed Al Touny Shebeen elkoom st., Ard mazad EL-moror ELkadeem, floor 4, flat 9, Ismailia, Egypt. Ismailia 41522 Egypt
Ahmed Ahmed Mohamed El lilly street 10, El gamaa elkadeema Ismailia 41522 Egypt
Ezzat Mohamed Al Taher Kilo 4.5, Ring road Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Abd Elnasser amiragamal22@gmail.com 00201003297302 Abou Horayra st. 5000 unit, building no. 124, dapartment No. 18
City Postal code Country Position/Affiliation
port said 42511 Egypt resident of Anaesthesia
Role Name Email Phone Street address
Principal Investigator shimaa Touny shimaa_touny@yahoo.com 00201004042654 Shebeen elkoom st., Ard mazad EL-moror ELkadeem, floor 4, flat 9, Ismailia, Egypt.
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed El liilly ahmed.lilly@gmail.com +201129111066 Street 10, El gamaa elkadeema
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Ezzat Al Taher ezzatme@gmail.com +201007336217 kilo 4.5, Ring road
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt professor of anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication Study Protocol beginning 9 months and ending 36 months following article publication for investigators whose proposed use of the data has been approved by an independent review committee. for individual participant data meta-analysis. proposal may be submitted up to 36 months following publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/01/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/01/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information