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.: PACTR202508594669644 Date of Registration: 01/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of General Anaesthesia with Erector Spinae Block for analgesia in patients undergoing breast surgery at a tertiary hospital in Ghana
Official scientific title Comparison of General Anaesthesia with Erector Spinae Block for analgesia in patients undergoing breast surgery at a tertiary hospital in Ghana
Brief summary describing the background and objectives of the trial Breast cancer is a significant health concern globally, and mastectomy is a common surgical intervention for its treatment. However, post-operative pain management remains a critical challenge, with many patients experiencing acute pain immediately after surgery and a subset developing chronic post-mastectomy pain syndrome (PMPS). Effective pain management is thus essential, not only for patient comfort but also for improving recovery outcomes and quality of life.This study aims at evaluating the analgesic effect of erector spinae block (ESPB), a regional anaesthetic technique and compare this with effect of general anaesthesia (intravenous opioids) for patients undergoing breast surgery at a tertiary hospital in Ghana. It will also determine the incidence of post mastectomy pain syndrome in these two groups of patients within six months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GAPSEB
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2025
Actual trial start date 08/09/2025
Anticipated date of last follow up 29/01/2027
Actual Last follow-up date 29/01/2027
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group General Anaesthesia with intravenous morphine IV morphine 0.1 - 0.15 mg/kg 6 months ● Induction of general anaesthesia ● Intubation will be performed for patients as per the standard hospital protocol ● Multimodal pre-emptive analgesia will be administered using intravenous paracetamol 1gand intravenous morphine 0.1 – 0.15 mg/kg before skin incision ● Maintenance of anaesthesia with isoflurane in oxygen ● Continuous monitoring of ECG, SPO2, and EtCO2 will be done and intermittent non-invasive blood pressure reading taken every 5 minutes. ● Upon completion of the surgery, the Anaesthesiologist will reverse the general anaesthesia and proceed to extubate the patient. ● Patients will be transferred to the recovery room or the intensive care unit (if patient requires this) ● Patients who require naloxone for reversal of opioid toxicity at the end of the procedure will be excluded from the study but post-operative monitoring will continue ● Post-operative monitoring of vital signs will be instituted and done every 15 minutes in the recovery room ● Pain assessment will be evaluated using the visual analogue scale on arrival in the recovery / ICU, 30 minutes, 60 minutes, 120 minutes and 240 minutes after surgery. 48 Active-Treatment of Control Group
Experimental Group Erector Spinae Block 0.5% bupivacaine 25 mls not exceeding maximum dose of 2mg/kg 6 months ● The patient will be positioned in a sitting position. ● The trunk of the patient will be uncovered, and the skin will be prepped with chlorhexidine gluconate. Throughout the process, sterile standards will be maintained. ● The ESPB will be performed by the Principal Investigator (PI) under ultrasound guidance. ● The linear ultrasound transducer will be put at the required level in a cephalocaudal position across the midline of the back. Gradually and laterally, the probe will be adjusted until the transverse process is apparent. At that position, the transverse process must be distinguished from the rib. The transverse process will be shallower and broader, whereas the rib will be deeper and thinner. The trapezius, rhomboid major, and erector spinae muscles will be recognised superficial to the transverse process after verification. ● Using a 22-gauge needle, a cumulative volume of 25 mL LA [bupivacaine (0.5%) not exceeding a maximum safe dose of 2mg/kg with dexamethasone (8 mg)] injection will be delivered in the space between the erector spinae muscle and the transverse process at level T4 to T7 with intermittent aspiration. The local anaesthetic agent will cause a visible separation between the erector spinae muscle and the transverse process. The confirmation of the needle's correct placement will be indicated by the observed separation between the muscle and the transverse process ● The spread of the injectate will be observed on ultrasound ● Following the conclusion of the block treatment, the patient will be put in a supine posture. All monitoring devices will be linked, and the absence of sensation to ice pack will be noted in dermatomes T1 to T8 o The patient will be transported to the operating room once he or she has lost feeling to ice pack sensation in T1 to T8 on the operative side o The total number of dermatomes exhibiting reduced pain sensation in response to ice pack, in comparison to the opposite side will be recorded o If there is no reduction 48
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants in the study will include: ● Patients who consent to the study ● Patients with breast malignancy ● Patients who are between 18 and 80 years of age ● Patients who are ASA I and II and scheduled for elective mastectomy The following participants will be ineligible for inclusion in the study. ● Patients who do not give consent ● Patients less than 18 years ● Patients greater than 80 years ● ASA III and IV patients for elective mastectomies ● Patients requiring emergency mastectomies ● Patients with inadequate ESPB (block failure) ● Patients who require naloxone on account of overdose of opioid Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 09/01/2025 Cape Coast Teaching Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Interbeton Cape Coast Teaching Hospital 0233 Ghana
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 16/09/2024 Health Research Ethics Committee of Stelenbosch University
Ethics Committee Address
Street address City Postal code Country
Baden- Powell, Stellenbosch off-ramp Stellenbosch 7602 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Onset of post-operative pain 30, 60, 120 and 240 minutes post operative
Secondary Outcome - Occurrence of Post Mastectomy Pain Syndrome and - Quality of life in those who develop Post Mastectomy Pain Syndrome monthly for 6 months in the post operative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cape Coast Teaching Hospital Interbeton Cape Coast 0233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Oluwayemisi Esther Ekor University of Cape Coast Road, Kwaprow Cape Coast 0233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oluwayemisi Esther Ekor University of Cape Coast Road, Kwaprow Cape Coast 0233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwayemisi Esther Ekor oluwayemisi.ekor@ucc.edu.gh +233540391878 University of Cape Coast Road, Kwaprow
City Postal code Country Position/Affiliation
Cape Coast 0233 Ghana Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Sean Chetty seanchetty@sun.ac.za +27837074444 Stellenbosch
City Postal code Country Position/Affiliation
Stellenbosch South Africa Professor
Role Name Email Phone Street address
Public Enquiries Oluwayemisi Esther Ekor oluwayemisi.ekor@ucc.edu.gh +233540391878 University of Cape Coast road, Kwaprow
City Postal code Country Position/Affiliation
Cape Coast Ghana Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De- identified participant data including demographics, baseline characteristics and outcome measures will be made available upon reasonable request after 12 months of publication of every result. Data will be shared via a secured repository and subject to approval of the principal investigator and ethics committee Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after publication of primary data. Access to de-identified individual participant data will be granted to qualified researchers upon submission of a methodologically sound proposal, subject to ethics approval and a signed data use agreement. Data will be shared for non-commercial research purposes only, and any attempt to re-identify participants will be strictly prohibited.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 31/07/2025 Changed from full capitals COMPARISON OF GENERAL ANAESTHESIA WITH ERECTOR SPINAE BLOCK FOR ANALGESIA IN PATIENTS UNDERGOING BREAST SURGERY AT A TERTIARY HOSPITAL IN GHANA Comparison of General Anaesthesia with Erector Spinae Block for analgesia in patients undergoing breast surgery at a tertiary hospital in Ghana
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 31/07/2025 Changed from full capitals COMPARISON OF GENERAL ANAESTHESIA WITH ERECTOR SPINAE BLOCK FOR ANALGESIA IN PATIENTS UNDERGOING BREAST SURGERY AT A TERTIARY HOSPITAL IN GHANA Comparison of General Anaesthesia with Erector Spinae Block for analgesia in patients undergoing breast surgery at a tertiary hospital in Ghana
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 31/07/2025 Brief background added The study aims at evaluating the analgesic effect of erector spinae block (ESPB), a regional anaesthetic technique and compare this with effect of general anaesthesia (intravenous opioids) for patients undergoing breast surgery at a tertiary hospital in Ghana. It will also determine the incidence of post mastectomy pain syndrome in these two groups of patients within six months. Breast cancer is a significant health concern globally, and mastectomy is a common surgical intervention for its treatment. However, post-operative pain management remains a critical challenge, with many patients experiencing acute pain immediately after surgery and a subset developing chronic post-mastectomy pain syndrome (PMPS). Effective pain management is thus essential, not only for patient comfort but also for improving recovery outcomes and quality of life.This study aims at evaluating the analgesic effect of erector spinae block (ESPB), a regional anaesthetic technique and compare this with effect of general anaesthesia (intravenous opioids) for patients undergoing breast surgery at a tertiary hospital in Ghana. It will also determine the incidence of post mastectomy pain syndrome in these two groups of patients within six months.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 31/07/2025 It was requested that each criteria is started on a new line Participants in the study will include patients ● who consent to the study ● with breast malignancy ● who are between 18 – 80 years of age ● who is ASA I and II for elective mastectomy Participants in the study will include: ● Patients who consent to the study ● Patients with breast malignancy ● Patients who are between 18 and 80 years of age ● Patients who are ASA I and II and scheduled for elective mastectomy
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/08/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/07/2025 To state the timing clearly Primary Outcome, Onset of post-operative pain, 30, 60, 120 and 240 minutes Primary Outcome, Onset of post-operative pain, 30, 60, 120 and 240 minutes post operative
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 31/07/2025 To ensure the timing stated is clear Secondary Outcome, - Occurrence of Post Mastectomy Pain Syndrome and - Quality of life in those who develop Post Mastectomy Pain Syndrome , monthly for 6 months Secondary Outcome, - Occurrence of Post Mastectomy Pain Syndrome and - Quality of life in those who develop Post Mastectomy Pain Syndrome , monthly for 6 months in the post operative period
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 31/07/2025 To state the name of the funder Self, University of Cape Coast Road, Kwaprow, Cape Coast, 0233, Ghana, Self Funded, Oluwayemisi Esther Ekor, University of Cape Coast Road, Kwaprow, Cape Coast, 0233, Ghana, Self Funded,