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.: PACTR202109731698164 Date of Approval: 23/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pectoral nerve block versus erector spinae plane block as analgesic modalities with pectointercoastal fascial plane block in modified radical mastectomy
Official scientific title Pectoral nerve block versus erector spinae plane block as analgesic modalities with pectointercoastal fascial plane block in modified radical mastectomy
Brief summary describing the background and objectives of the trial Owing to the high incidence of breast carcinoma, modified radical mastectomy (MRM) had become one of the most common surgeries. Postmastectomy pain syndrome (PMPS) is a complex disorder associated with MRM which limits the normal functionality and affect the overall quality of life. (Fecho et al., 2009)The incidence of chronic pain after mastectomy is as high as 25–60%. (Andresen et al., 2011)With the introduction of ultrasound technology into regional anesthesia and pain management routines, the popularity of interfascial plane blocks has increased. (Chin et al., 2019) Based on the origin, alignment, branches, and distribution of the intercostal nerves within the anterior thoracic region, postoperative analgesia in breast cancer patients can be done by different nerve blocks as apart of multimodal analgesia.This study aims to compare and evaluate the differences between the two combined techniques: pectoral nerve block with Pectointercoastal fascial plane block and erector spinae plane block with Pectointercoastal fascial plane block as regard the analgesic profile in modified radical mastectomy.Pectoral nerve (PECS) block is an interfascial plane block with reported analgesic efficacy following mastectomy. (Blanco R., 2011). PECS I involves injection of local anesthetics in the tissue plane situated between the pectoralis major and minor muscles. PECS II is an extension of PECS I, with placement of additional local anesthetic between pectoralis minor and serratus anterior muscle (SAM). (Blanco et al., 2012)Pectointercostal fascial plane block (PIFPB) targets the anterior cutaneous branch of the intercostal nerve (Lopez-Matamala et al., 2014)The erector spinae plane (ESP) block is simple and safe technique alternative to paravertebral block. (Ueshima et al., 2017) It involves injection of local anesthetic into the musculofascial plane deep to the erector spinae muscle and superficial to the tips of the transverse processes. (Voscopoulos et al., 2013)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 12/09/2021
Actual trial start date 18/09/2021
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 20/10/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PECS block with PIFPB will receive 10 ml of 0.5% isobaric bupivacaine for PECS I and 20 ml of 0.25% isobaric bupivacaine for PECS II 15 ml of 0.25% isobaric bupivacaine for PIFPB After induction of anaesthesia Ultrasound-Guided PECS Block include PECS I block and PECS II, Patients are placed in the supine position on an operating table with their arm abducted. The probe is positioned below the lateral third of the clavicle. Positions of the axillary artery and vein are confirmed, and the ultrasound probe then moves inferolaterally until the pectoralis major and minor and the serratus anterior muscle are identified in one plane at the level between the third and fourth ribs. The needle is advanced in plane view of the ultrasound probe from the medial to lateral direction until it reaches the interfascial plane between the pectoralis major and minor muscles. After the position of the needle tip is confirmed by hydro dissection with 2 ml normal saline, 10 ml of 0.5% bupivacaine is administered. The needle is subsequently advanced further until its tip is located in the interfascial plane between the pectoralis minor and serratus anterior muscle, and an additional 20 ml of 0.25% bupivacaine is administered above the serratus anterior muscle.Ultrasound guided PIFPB patients are in supine position, the probe is placed 2 or 3 cm parallel to the long axis of the sternal bone to identify the second to fourth costal cartilages and targeting the fourth costal cartilage. The needle is inserted in-plane with the ultrasound probe, in a caudal-to-cranial direction. The needle is advance until the tip is positioned in the interfascial plane between the pectoralis major muscle and the external intercostal muscle. After confirmation of the correct position of the tip of the needle by separation of the fascial layers on injecting 2 mL normal saline solution, total volume 15 mL of bupivacaine 0.25% is injected. 50 Dose Comparison
Experimental Group ESPB with PIFPB will receive 40ml of 0.25% isobaric bupivacaine for ESPB, 15 ml of 0.25% of isobaric bupivacaine 15 ml of 0.25% of isobaric bupivacaine After induction of anaesthesia Ultra sound guided ESPB patients are positioned in lateral decubitus position with operative side upward. The spine is palpated from the seventh cervical spinous process (C7) downward to the thoracic fourth spinous process (T4) and the point is marked. There for the probe is placed 3 cm lateral to the T4 spinous process on the operating side to visualize and identify trapezius, rhomboid major and erector spinae muscles from outward the spinal needle is inserted in the plane cranial to caudal till the tip of the needle reached into the fascial plane between the erector spinae muscle and transverse process. The position of the needle tip is confirmed by hydro dissection with 2 ml normal saline, a total of 40 ml 0.25% bupivacaine is injected with intermittent aspiration. The spread of injectate in both cranial and caudal directions is seen on ultrasound.Ultrasound guided PIFPB patients are in supine position, the probe is placed 2 or 3 cm parallel to the long axis of the sternal bone to identify the second to fourth costal cartilages and targeting the fourth costal cartilage. The needle is inserted in-plane with the ultrasound probe, in a caudal-to-cranial direction. The needle is advance until the tip is positioned in the interfascial plane between the pectoralis major muscle and the external intercostal muscle. After confirmation of the correct position of the tip of the needle by separation of the fascial layers on injecting 2 mL normal saline solution, total volume 15 mL of bupivacaine 0.25% is injected. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Female patient 2. Age: 30-65 3. American society of anaesthesiologist grade I, II 1. Patient refusal 2. Infection at the site of the block 3. Coagulopathy 4. Allergy to local anaesthetic 5. BMI >35 kg/ m² 6. Bilateral MRM Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 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 21/07/2021 Mansoura faculty of medecine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gomhoria street Mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total analgesic consuption 24 hours after surgery
Secondary Outcome duration of analgesia (time of first analgesic request), amount of intraoperative consumed opioids, postoperative visual analogue score (VAS), the effect on hemodynamics, complication of the block and postoperative nausea and vomiting (PONV). 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El Gomhoria street Mansoura 35546 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El Gomhoria street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Olfat mostafa ismail 2 El Gomhoria street Mansoura 35516 Egypt
Hazed Elsayed Moawad 2 El Gomhoria street Mansourah 35516 Egypt
Abd el hamid zehry 2 El Gomhoria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam EL mekawy islamfarahat193@yahoo.com 00201223605695 2 El Gomhoria streety
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt specialist of anaesthesia and surgical ICU at MOH
Role Name Email Phone Street address
Public Enquiries Olfat Ismail olfatmi@hotmail.com 0021223163041 2 El Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of anaesthesia and surgical ICU at faculty of medecine mansoura university
Role Name Email Phone Street address
Scientific Enquiries Hazem Moawad hazemmoawad@yahoo.com 00201121516041 2 El Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anaesthesia and surgical ICU at faculty of medecine mansoura uneversity
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will provide individual participant data and share it through the Pupmed indexed journal Informed Consent Form,Study Protocol Begining 6 months and ending 12 monthsfollowing article puplication we will provide individual participant data and share it through the Pupmed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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