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.: PACTR202408744793714 Date of Approval: 15/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of dexmedetomidine- bupivacaine versus nalbuphine-bupivacaine in ultrasound-guided deep serratus anterior plane block on the quality of recovery following modified radical mastectomy
Official scientific title Efficacy of dexmedetomidine- bupivacaine versus nalbuphine-bupivacaine in ultrasound-guided deep serratus anterior plane block on the quality of recovery following modified radical mastectomy
Brief summary describing the background and objectives of the trial After general anesthetic technique standardized to all participants in the form of propofol 1.5mgLkg, atracurium 0.5mgLkg and naluphine 10 mg Patients were randomly allocated into one of three equal groups( 30 patients each ) Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 20 ml. Of 0.25 % isobaric bupivacaine with addition of 1ug/kg dex to be diluted with isotonic saline to 2 ml(22 ml.total volume). Group (B-N) (n=30): will receive unilateral USG-deep SAPB 20 ml. Of 0.25% isobaric bupivacaine with addition of 5 mg nalbuphine to be diluted with isotonic saline to 2 ml(22 ml.total volume). Group (B- P)( n=30): will receive unilateral USG-deep SAPB 20 ml. Of 0.25 %isobaric bupivacaine with addition of 2 ml. isotonic saline (22 ml.total volume). with the patient in the lateral position with block site facing up exposing their lateral chest wall at the level of fourth and fifth ribs in the mid-axillary line.We used Korean Siemens ACUSON X300 ultrasound device in all patients. we get the better view of the relevant anatomical structures, latissimus dorsi muscle LD (lying superficial) and serratus anterior SA (lying deep just above the ribs) thoracodorsal artery and sliding pleura was identified at the onset of scanning and care was taken to avoid them. Under complete aseptic technique, the needle (22 gauge spinal needle) was inserted in plane of the ultrasound beam from posteromedial to anterolateral direction till reaching the fascia between the serratus anterior muscle and the intercostal muscles. After confirming the plane between the two muscles with hydrodissection by saline negative aspiration was done then the injectate was given according to the group. 15 minutes later the surgeon started. Post operative assessment -QoR-15 at 24 hour postop -VAS : 2;4;6;12 and 24 hoursThe present study aims to investigate whether combined dexmedetomidine-bupivacaine or nalbuphine -bupivacaine (SAPB) was effective in improving Quality of recovery post operative
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/12/2023
Actual trial start date 07/01/2024
Anticipated date of last follow up 25/04/2024
Actual Last follow-up date 30/04/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL irb.mans.edu.eg
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 Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group injection The anaesthesiologist who will be responsible for the patient and records the data will be unaware of patients group allocation .Patients will be randomly allocated into one of three equal groups( 30 patients each ). The study group Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 0.5 ug/kg dex to be diluted with isotonic saline (30 ml total volume). Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine with addition of 10 mg nalbuphine to be diluted with isotonic saline (30 ml total volume). Group (B- P)( n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 %isobaric bupivacaine (30 ml total volume). The general anesthetic technique will be standardized to all participants in the form of propofol 1.5mgLkg, atracurium 0.5mgLkg and naluphine 10 mg as analgesic then anesthesia maintained by isoflurane one MAC in oxygen 40% . After that the SAPB will be done to the patient using Ultrasound machine.15 minutes later the surgeon will be allowed to start dissection of the breast tissue. Heart rate (HR) and mean arterial blood pressure (MBP) will be recorded and reported according to the later program scedule. Post operative assessment QoR-15 at 24 hour postop- VAS : 2;4;6;12 and 24 hours- -Hemodynamic assessment : HR and MAP intraop at 10 min intervals and post op at 2;4;6;12 and 24 hours -Assessment of post op sedation using Ramsay sedation scale at 2;4 ; 6 and 12 hours post op This block will be performed with the patient in the lateral position with block site facing up and the patient's non-dependent arm resting comfortably above their heads, exposing their lateral chest wall at the level of fourth and fifth ribs in the mid-axillary line . We will use Korean Siemens ACUSON X300 ultrasound device in all patients. For right-sided surgery the anaesthetist performing the block should stand on the right side at the head end, with transducer in left hand (for a right sided block), and needle in right hand, while the ultrasound monitor is placed on the other side, so that the operator can have a clear view of both the block area and the screen at the same time. We will start by sterilization of the area of block around the area of mid-axillary by antiseptic solution. We will use a high frequency ultrasound probe (13-16 MHz). Scans will be performed while moving the transducer laterally and distally for counting the ribs from below until the 4th and 5th ribs will be visualized. The transducer will then be rotated into the coronal plane and tilted posteriorly until we get the better view of the relevant anatomical structures, latissimus dorsi muscle LD (lying superficial) and serratus anterior SA (lying deep just above the ribs) thoracodorsal artery and sliding pleura will be identified at the onset of scanning and care will be taken to avoid them. Under complete aseptic technique, the needle (22 gauge spinal needle) will be inserted in plane of the ultrasound beam from posteromedial to anterolateral direction till reaching the fascia between the serratus anterior muscle and the intercostal muscles. After confirming the plane between the two muscles with hydrodissection by saline negative aspiration will be done then the injectate will be given according to the group. Group I( B-D) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 0.5 ug/kg dex to be diluted with isotonic saline (30 ml total volume). Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine with addition of 10 mg nalbuphine to be diluted with isotonic saline (30 ml total volume). Group (B- P)( n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 %isobaric bupivacaine (30 ml total volume). 30
Experimental Group injection Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% isobaric bupivacaine with addition of 10 mg nalbuphine to be diluted with isotonic saline (30 ml total volume). single injection and follow up for 24 hours This block will be performed with the patient in the lateral position with block site facing up and the patient's non-dependent arm resting comfortably above their heads, exposing their lateral chest wall at the level of fourth and fifth ribs in the mid-axillary line . We will use Korean Siemens ACUSON X300 ultrasound device in all patients. For right-sided surgery the anaesthetist performing the block should stand on the right side at the head end, with transducer in left hand (for a right sided block), and needle in right hand, while the ultrasound monitor is placed on the other side, so that the operator can have a clear view of both the block area and the screen at the same time. We will start by sterilization of the area of block around the area of mid-axillary by antiseptic solution. We will use a high frequency ultrasound probe (13-16 MHz). Scans will be performed while moving the transducer laterally and distally for counting the ribs from below until the 4th and 5th ribs will be visualized. The transducer will then be rotated into the coronal plane and tilted posteriorly until we get the better view of the relevant anatomical structures, latissimus dorsi muscle LD (lying superficial) and serratus anterior SA (lying deep just above the ribs) thoracodorsal artery and sliding pleura will be identified at the onset of scanning and care will be taken to avoid them. Under complete aseptic technique, the needle (22 gauge spinal needle) will be inserted in plane of the ultrasound beam from posteromedial to anterolateral direction till reaching the fascia between the serratus anterior muscle and the intercostal muscles. After confirming the plane between the two muscles with hydrodissection by saline negative aspiration will be done then the injectate will be given according to the group. 30
Control Group injection Group (B- P)( n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 %isobaric bupivacaine (30 ml total volume). single injection and follow up for 24 hours This block will be performed with the patient in the lateral position with block site facing up and the patient's non-dependent arm resting comfortably above their heads, exposing their lateral chest wall at the level of fourth and fifth ribs in the mid-axillary line . We will use Korean Siemens ACUSON X300 ultrasound device in all patients. For right-sided surgery the anaesthetist performing the block should stand on the right side at the head end, with transducer in left hand (for a right sided block), and needle in right hand, while the ultrasound monitor is placed on the other side, so that the operator can have a clear view of both the block area and the screen at the same time. We will start by sterilization of the area of block around the area of mid-axillary by antiseptic solution. We will use a high frequency ultrasound probe (13-16 MHz). Scans will be performed while moving the transducer laterally and distally for counting the ribs from below until the 4th and 5th ribs will be visualized. The transducer will then be rotated into the coronal plane and tilted posteriorly until we get the better view of the relevant anatomical structures, latissimus dorsi muscle LD (lying superficial) and serratus anterior SA (lying deep just above the ribs) thoracodorsal artery and sliding pleura will be identified at the onset of scanning and care will be taken to avoid them. Under complete aseptic technique, the needle (22 gauge spinal needle) will be inserted in plane of the ultrasound beam from posteromedial to anterolateral direction till reaching the fascia between the serratus anterior muscle and the intercostal muscles. After confirming the plane between the two muscles with hydrodissection by saline negative aspiration will be done then the injectate will be given according to the group. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female gender scheduled for unilateral MRM -ASA :I-II Age: 20-60 y patient refusal to participate in the study -BMI>40kg/m2 -infection at site of needle insertion -hypersensitivity to the studied drugs -psychotic disorders -Bilateral MRM -bleeding disorders -chronic renal hepatic disease Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 10/12/2023 irb faculty of medicine mansoura univerisity
Ethics Committee Address
Street address City Postal code Country
el gomhoria street faculty of medicine mansoura univerisity mansoura 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of recovery as physical and mental well-being according to quality of recovery -15 24 hours after operation
Secondary Outcome VAS visual analogue scale scored from 0-10( where 0=no pain) and 10 = the worst pain imaginable at 2 hours then 4 hours then 6 h then 12 then 24 hours after operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
oncology center faculty of medicine mansoura univerisity el gomhoria street faculty of medicine mansoura univerisity mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine mansoura univerisity el gomhoria street faculty of medicine mansoura univerisity mansoura 23122408 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura univerisity el gomhoria street faculty of medicine mansoura univerisity Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator salma ahmed salmaelsayed84@yahoo.com +201002990553 el gomhoria street faculty of medicine mansoura univerisity
City Postal code Country Position/Affiliation
mansoura Egypt lecturer of anaesthesia and surgical intensive care faculty of medicine mansoura univerisity
Role Name Email Phone Street address
Public Enquiries ehab mokbel salmaelsayed84@mans.edu.eg +201002990553 el gomhoria street faculty of medicine mansoura univerisity
City Postal code Country Position/Affiliation
mansoura Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries hatem saber Salmaelsayed84@mans.edu.eg +201002990553 el gomhoria street faculty of medicine mansoura univerisity
City Postal code Country Position/Affiliation
mansoura Egypt professor of anaethesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be available after publishing the paper It will include the result reported in this article (text, tables, figures and appendices) and other documents like protocol,, statistical analysis, consent form will be available also one year following publication no end date The individual participant will be unidentified IPD will be available for individual participant data meta-analysIPD will be available for researchers. proposal should be directed the mail of main investigator (ehabmokbel@yahoo.com) to gain access after one year of publication researchers can request data allowed from the main investigator at his mail (ehabmokbel@yahoo.com) Study Protocol one year following publication no end date IPD will be available after publishing the paper It will include the result reported in this article (text, tables, figures and appendices) and other documents like protocol,, statistical analysis, consent form will be available also one year following publication no end date The individual participant will be unidentified IPD will be available for individual participant data meta-analysIPD will be available for researchers. proposal should be directed the mail of main investigator (ehabmokbel@yahoo.com) to gain access after one year of publication researchers can request data allowed from the main investigator at his mail (ehabmokbel@yahoo.com)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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