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.: PACTR202509579633417 Date of Registration: 11/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing the efficacy of bupivacaine alone and bupivacaine with dexamethasone in prolonging analgesia following supraclavicular brachial plexus block in patients undergoing upper‑limb surgeries in Halibet National Referral Hospital, Eritrea 2024-2025
Official scientific title The Effect of Intravenous Dexamethasone in Prolonging Analgesia after Supraclavicular Brachial Plexus Block in Patients who Underwent Upper–Limb Surgeries in Halibet National Referral Hospital, Eritrea 2024-2025
Brief summary describing the background and objectives of the trial Post-operative pain creates a burden for the patient and their family members while also drastically increasing the cost of the health care service. Supraclavicular brachial plexus block provides the optimal operating conditions for upper arm surgery but for limited time. There are several adjunct medications that can be combined with peripheral nerve block to prolong the duration of action and to provide longer period of analgesia. Dexamethasone is a glucocorticoid that has been shown to increase the efficacy of peripheral nerve block. The study was conducted to compare the effects between adding dexamethasone or alone to bupivacaine for prolongation of analgesia. A prospective comparative interventional study was conducted and 30 patients who underwent upper limp surgeries were included through random allocation of participants into two comparable 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 Education /Training
Anticipated trial start date 01/12/2024
Actual trial start date 01/01/2025
Anticipated date of last follow up 01/02/2025
Actual Last follow-up date 01/02/2025
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
Ministry of Health
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bupivacaine and Dexamethasone Group Participants in this group received 20ml of 0.5% of bupivacaine with 8mg of dexamethasone IV 24 hours follow up Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough pre­anesthetic evaluation was done. Previous anesthetic exposure and drug sensitivity were enquired. Routine preoperative laboratory investigations were conducted. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure evaluation and pulse oximetry and baseline vital signs were recorded before the start of the procedure. During the intraoperative period, the intravenous line was secured with a lactated Ringer’s solution or normal saline for all participants. Participants in this group received 20ml of 0.5% of bupivacaine with 8mg of dexamethasone IV in supraclavicular brachial plexus block in sitting position. Patients was then be monitored in the ward for postoperative care and Pain assessment. It was conducted after patients are transferred to the ward. The pain scoring was conducted at 1st 2nd 4th 6th 8th 12th and 24th hour post-operatively which was a total of 7 times of follow up. The NRS was utilized to assess the degree of pain and the checklist was used to score the results. Any patient in either group who develops severe pain, additional analgesic was given or those who develop other undesirable postoperative complications, they were taken care of accordingly. 30
Control Group Bupivacaine Group Participants in this group received 20ml of 0.5% of bupivacaine alone 15 minutes before supraclavicular injection Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough pre­anesthetic evaluation was done. Previous anesthetic exposure and drug sensitivity were enquired. Routine preoperative laboratory investigations were conducted. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure evaluation and pulse oximetry and baseline vital signs were recorded before the start of the procedure. During the intraoperative period, the intravenous line was secured with a lactated Ringer’s solution or normal saline for all participants. Participants in this group received 20ml of 0.5% of bupivacaine alone in supraclavicular brachial plexus block in sitting position. Patients was then be monitored in the ward for postoperative care and Pain assessment. It was conducted after patients are transferred to the ward. The pain scoring was conducted at 1st 2nd 4th 6th 8th 12th and 24th hour post-operatively which was a total of 7 times of follow up. The NRS was utilized to assess the degree of pain and the checklist was used to score the results. Any patient in either group who develops severe pain, additional analgesic was given or those who develop other undesirable postoperative complications, they were taken care of accordingly 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients of either male or female, Age 18 to 80 years, ASA I or II patients, Elective orthopedic surgery such as elbow, forearm and hand under supraclavicular brachial plexus block Patient refusal, Contraindication to SCBPB block such as severe chronic obstructive pulmonary disease, infection, Contralateral diaphragmatic paralysis, Neuropathy of the surgical limb, Pregnant women, Any bleeding disorder, Local infection at the injection site, Known allergy to LAs, Long term steroid therapy, Patients taking Opioids, Ketamine, NSAID during study period Diabetes mellitus, Hepatic and Renal disease 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s) 18 Year(s) 80 Year(s) Both
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 10/09/2024 Ministry of Health Research and Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Wakiro Street Asmara 0000 Eritrea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The addition of dexamethasone 8 mg IV to 0.5% bupivacaine in supraclavicular brachial plexus block prolongs the duration of analgesia in the postoperative period significantly when compared to use of bupivacaine alone The pain scoring was conducted at 1st 2nd 4th 6th 8th 12th and 24th hour post-operatively which was a total of 7 times of follow ups
Secondary Outcome The secondary outcomes can be explained by the secondary effect of the provided interventions. On top of the primary outcome, they also have a secondary outcome on the patient conditions such as fastens the onset of action of sensory and motor block and reduce the postoperative analgesic consumption. Time at which secondary outcome was measured is similar to that of primary outcome
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Halibet National Referral Hospital Eritrea Asmara Asmara 0000 Eritrea
FUNDING SOURCES
Name of source Street address City Postal code Country
Orotta College of Medicne and Health Sciences Seharti Asmara 0000 Eritrea
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Orotta College of Medicine and Health Sciences Seharti Asmara 0000 Eritrea University
Primary Sponsor Ministry of Health Research policy and HRD department Wakiro Asmara 0000 Eritrea Hospital
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health of Eritrea Asmara Asmara 0000 Eritrea
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Beraki mikoberaki88@gmail.com 2917305987 Glee
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea Primary Investigator
Role Name Email Phone Street address
Public Enquiries Sabri Hashim sabrinahash@gmail.com 2917174705 Asmara
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea Publc Enquiries
Role Name Email Phone Street address
Scientific Enquiries Senay Amare senay7amare@gmail.com 2917514393 Asmara
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea Scientifc Inquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after identification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data o Data will be available for any purpose and indefinitely
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 26/08/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/08/2025 Result - 26/08/2025 Result - 26/08/2025 Result - 26/08/2025 Result - 26/08/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 28/08/2025 inclusion criteria are listed on a new line Adult patients of either sex, Age 18 to 80 years, ASA I or II patients, Elective orthopedic surgery such as elbow, forearm and hand under supraclavicular brachial plexus block Adult patients of either male or female, Age 18 to 80 years, ASA I or II patients, Elective orthopedic surgery such as elbow, forearm and hand under supraclavicular brachial plexus block
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 28/08/2025 inclusion criteria are listed on a new line Patient refusal, Contraindication to SCBPB block (severe chronic obstructive pulmonary disease, infection, contralateral diaphragmatic paralysis, neuropathy of the surgical limb), Pregnant women, any bleeding disorder, Local infection at the injection site, known allergy to LAs, Long term steroid therapy, any premedication that alters our result (Opioids, Ketamine, NSAID), Diabetes mellitus, Hepatic and Renal disease Patient refusal, Contraindication to SCBPB block such as severe chronic obstructive pulmonary disease, infection, Contralateral diaphragmatic paralysis, Neuropathy of the surgical limb, Pregnant women, Any bleeding disorder, Local infection at the injection site, Known allergy to LAs, Long term steroid therapy, Patients taking Opioids, Ketamine, NSAID during study period Diabetes mellitus, Hepatic and Renal disease
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 28/08/2025 Actually, it's between 18 and 80 years old Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 05/09/2025 Age groups are between 18 and 80 years Adult: 19 Year-44 Year, Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 28/08/2025 Secondary IDs is applicable , Ministry of Health
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 28/08/2025 The hospital is the sole orthopedic hospital that provides orthopedic surgeries. Therefore, I belief this explains the reason it's done in a single hospital. Halibet National Referral Hospital, Asmara, Asmara, 0000, Eritrea Halibet National Referral Hospital Eritrea, Asmara, Asmara, 0000, Eritrea
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/09/2025 Updated Headed letter of the ethical clearance TRUE, Ministry of Health Research and Ethical Committee, Wakiro Street, Asmara, 0000, Eritrea, , 10 Sep 2024, 2911122983, baghilaga2014@gmail.com, 37052_33228_4737.pdf TRUE, Ministry of Health Research and Ethical Committee, Wakiro Street, Asmara, 0000, Eritrea, , 10 Sep 2024, 2911122983, baghilaga2014@gmail.com, 37052_33228_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 29/08/2025 It's a governmental college and hospital Orotta College of Medicne and Health Sciences, Seharti, Asmara, 0000, Eritrea, Self Funded, Orotta College of Medicne and Health Sciences, Seharti, Asmara, 0000, Eritrea, Government Body,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 29/08/2025 Ministry of Health is the key collaborator for this trial Ministry of Health of Eritrea, Asmara, Asmara, 0000, Eritrea