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.: PACTR201912757049808 Date of Approval: 04/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dual Pectoral Nerve and Serratus Anterior Plane Blocks for postoperative analgesia after Breast Surgery: Placebo-controlled comparative study versus Paravertebral Block
Official scientific title Dual Pectoral Nerve and Serratus Anterior Plane Blocks for postoperative analgesia after Breast Surgery: Placebo-controlled comparative study versus Paravertebral Block
Brief summary describing the background and objectives of the trial Objectives: Evaluation of outcome of pain management after modified radical mastectomy using combined pectoral nerve block I (PEC I) and serratus anterior block (SAB) versus thoracic paravertebral block (PVB). Patients & Methods: 66 women were randomly divided into Control group (Group N) included patients received no local anesthetic (LA) block, Group A included patients received ultrasound-guided PVB and Group B included patients received US-guided PEC I and SAB. Rescue analgesia was provided as IV morphine (0.05-0.1 mg/kg). Primary outcome was the reduction of 24-hr postoperative (PO) morphine consumption by 20% difference between studied groups.
Type of trial CCT
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 Prevention
Anticipated trial start date 01/12/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 01/04/2020
Actual Last follow-up date 01/04/2020
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants) 66
Recruitment status Not yet recruiting
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 created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group without any block throughout the surgery included patients received no LA block. 22 Placebo
Experimental Group Serratus and pec I block throughout the procedure included patients received ultrasound-guided PVB: after skin closure and covering of wound area, patient was placed in lateral position to expose the side ipsilateral to the site of surgery. Then, a 6-13 MHz linear transducer (Sonosite, MicroMaxx machine, USA) was placed parallel to vertebral column to identify the spinous process of T4 and then moved laterally to identify its transverse process searching for the costotransverse ligament (CTL) to identify the paravertebral space and its site was confirmed by viewing the echogenic line of the pleura underneath of CTL. Then, a 22-gauge Quincke's spinal needle was advanced in the plane and 35 ml of 0.25% bupivacaine with epinephrine 15 ug/ml was injected in the paravertebral space. 22
Experimental Group Thoracic paravertebral block throughout the procedure included patients received US-guided PEC I and SAB; after skin closure and covering of wound area, while patient was in supine position with ipsilateral arm was abducted above the head, skin at the infra-clavicular region was sterilized, a 6-13 MHz linear transducer (Sonosite, MicroMaxx machine, USA) was placed infra-clavicular, moved laterally to locate the axillary artery and vein directly above the 1st rib to identify the pectoral muscles, a 22-gauge Quincke's spinal needle was inserted between pectoralis major and minor muscles to inject 10 ml 0.25% bupivacaine with epinephrine 15 ug/ml in the fascial plane between the two muscles. Thereafter, the US probe was placed over the 5th rib in the mid axillary line and under US-guidance a 22-gauge Quincke's spinal needle was directed towards the inter-fascial plane between the serratus anterior muscle and external intercostal muscle, needle site was assured by injection of 3-ml of normal saline to create of hydro dissection, and then a bolus of 25 ml bupivacaine 0.25% with epinephrine 15 ug/ml was administered into that plane. 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women aged 20-70 years and assigned for modified radical mastectomy (Patey' Procedure) were eligible for evaluation. Exclusion criteria included: -ASA grades III and IV, -body mass index (BMI) ≥35 kg/m2, -chest or spine abnormalities, -previous chest surgery, - history of previous fracture rib, - neurological diseases, -peripheral neuropathy, -coagulopathies, - allergy to local anesthetics (LA), - inability to interpret the used pain score - refusal to sign the written consent. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 01/06/2016 Aswan university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
el seel street Aswan 097348223 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome was the reduction of 24-hr PO mean amount of morphine consumption by 20% difference between studied groups. postoperative
Secondary Outcome 2. Secondary outcome - PO pain severity as judged immediately after extubation (time 0), at 30-min, 2, 4, 8, 12, 18 and 24-hr PO using NRS score - Duration of PO analgesia, defined as duration of analgesia till having NRS score ≥4 and receiving morphine as rescue analgesia. - Development of block injection-related complication, LA side effects or rescue analgesia induced side effects. postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aswan university El seel street Aswan 097348223 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif kamal Hafez Arafa Egypt- Gharbia- Tanta Gharbia 040331111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir Abouzkry Egypt - Shebeen Shebeen 040323070 Egypt Funding Agency
Secondary Sponsor Sherif kamal arafa Egypt- Tanta Gharbia Tanta 040331111 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa Egypt- Gharbia- Tanta Gharbia 040331111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifarafa1020@gmail.com 00201005714014 Egypt-Gharbia-Tanta
City Postal code Country Position/Affiliation
Gharbia 040331111 Egypt Lecturer of anesthesia and ICU in Kfer El Shigh university
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifarafa1020@gmail.com 00201005714014 Egypt-Gharbia-Tanta
City Postal code Country Position/Affiliation
Gharbia 040331111 Egypt Lecturer of anesthesia and ICU in Kfer El Shigh university
Role Name Email Phone Street address
Scientific Enquiries Amir Abuzikary aabozikry@yahoo.com 00201016326544 Egypt- Shebeen
City Postal code Country Position/Affiliation
Shebeen 040331111 Egypt Lecturer of anesthesia and ICU in Aswan university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - PO pain severity as judged immediately after extubation (time 0), at 30-min, 2, 4, 8, 12, 18 and 24-hr PO using NRS score - Duration of PO analgesia, defined as duration of analgesia till having NRS score ≥4 and receiving morphine as rescue analgesia. - Development of block injection-related complication, LA side effects or rescue analgesia induced side effects. Study Protocol 3 years To those who request the data via e-mail of the principal investigator according to the cause of request
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