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.: PACTR202112778684666 Date of Approval: 17/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative study between the efficacy of bupivacaine plus nalbuphine versus bupivacaine alone in pectoral nerve block for management of postoperative pain in patients undergoing breast fibroadenoma excision.
Official scientific title A comparative study between the efficacy of bupivacaine plus nalbuphine versus bupivacaine alone in pectoral nerve block for management of postoperative pain in patients undergoing breast fibroadenoma excision.
Brief summary describing the background and objectives of the trial Breast surgeries, even the relatively minor ones, can be associated with significant postoperative pain affecting patients’ physical and psychological well-being. Thus, regional anaesthetic techniques have been used for anaesthesia and analgesia of breast surgery, PECS I and II blocks have been proven to be relatively easy and safe in such regards. Moreover, using adjuvants, such as nalbuphine, have been proposed by many studies to intensify the block and decrease postoperative analgesic intake. The aim of this study is to assess the efficacy of adding nalbuphine (20 mg) as an adjuvant to bupivacaine 0.25% (10 mls) in PECS I block compared to injecting bupivacaine 0.25% (10 mls) alone in fibroadenoma excision patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Test the efficacy if nalbuphine as an adjuvant to bupivacaine in PECS block
Anticipated trial start date 03/04/2021
Actual trial start date
Anticipated date of last follow up 13/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PECS I Block with bupivacaine 0.25 percent alone 10 mls of bupivacaine 0.25 per cent alone Not applicable The PECS I block was performed while the patient in the supine position with the ipsilateral upper limb was abducted 90 degrees using (Sonosite ® M-Turbo C U.S.A) linear array ultrasound probe of high frequency (6-13 Mhz) placed medial to the coracoid process, the probe is then tilted medially and moved distally and laterally until the 3rd rib is visualised, a 22 gauge Quincke’s spinal needle will be inserted in-plane in the plane between the pectoralis major and minor muscles and 10 mL of bupivacaine 0.25% will be injected after negative aspiration, preferably in vicinity of the thoracoacromial artery. 30 Active-Treatment of Control Group
Experimental Group PECS I with bupivacaine 0.25 per cent plus 20 mg of nalbuphine 10 mls of bupivacaine 0.25% plus 20 mg of nalbuphine Not applicable The PECS I block was performed while the patient in the supine position with the ipsilateral upper limb was abducted 90 degrees using (Sonosite ® M-Turbo C U.S.A) linear array ultrasound probe of high frequency (6-13 Mhz) placed medial to the coracoid process, the probe is then tilted medially and moved distally and laterally until the 3rd rib is visualised, a 22 gauge Quincke’s spinal needle will be inserted in-plane in the plane between the pectoralis major and minor muscles and 10 mL of bupivacaine 0.25% will be injected after negative aspiration, preferably in vicinity of the thoracoacromial artery. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I & II Female patients 18 - 60 years old 50 – 90 kg Undergoing elective fibroadenoma excision surgery Patient’s refusal Patients with a history of bleeding disorders, relevant drug allergy Infection at the site of needle entry Pregnancy and lactation Patients with advanced cardiovascular and psychiatric diseases Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 08/01/2018 Ain Shams University Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS at 0, 1, 2, 4, 6, 12 and 24 hrs postoperatively.
Secondary Outcome Total morphine consumption during 24 hour period post-surgery
Secondary Outcome Time to the first analgesic during 24 hour period post-surgery
Secondary Outcome Vital signs including blood pressure, heart rate and respiratory rate. at 0, 1, 2, 4, 6, 12 and 24 hrs postoperatively.
Secondary Outcome Oxygen saturation at 0, 1, 2, 4, 6, 12 and 24 hrs postoperatively.
Secondary Outcome Adverse effects such as nausea, vomiting, sedation during 24 hour period post-surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals 56 Ramsees St., Abbassia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Mohammed 56 Ramsees St, Abbassia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesia ICU Pain Medicine Faculty of Medicine Ain Shams University 56 Ramsees St., Abbassia Cairo 11591 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Samia Abdelmohsen Abdel Latif 56 Ramsees St., Abbassia Cairo 11591 Egypt
Prof. Dr. Dalia Abdelhamid Nasr 56 Ramsees St., Abbassia Cairo 11591 Egypt
Dr. Mostafa Mohamed Serry 56 Ramsees St., Abbassia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mohammed mms78@hotmail.com +201062964333 56 Ramsees St., Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Lecturer of Anaesthetics ICU Pain Medicine
Role Name Email Phone Street address
Public Enquiries Mostafa Mohammed mms78@hotmail.com +201062964333 56 Ramsees St, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Lecturer of Anaesthesia ICU Pain Medicine
Role Name Email Phone Street address
Scientific Enquiries Dalia Nasr dhalia.a.nasr@hotmail.com +201223515195 56 Ramsees St, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia Intensive Care and Pain Medicine.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/12/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information