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.: PACTR202402842689533 Date of Approval: 01/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesia after shoulder arthroscopy
Official scientific title Cervical Erector Spinae Plane Block versus Posterior Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy: A Prospective Randomised Parallel Trial
Brief summary describing the background and objectives of the trial Severe perioperative pain is a serious condition following shoulder arthroscopy. We aim to assess the intraoperative and postoperative analgesic efficacy of cervical ESPB in patients undergoing shoulder arthroscopy. On arrival to the operative room, the anesthesiologist responsible for administering the block from the researcher anesthesia team will open the envelope. Noninvasive blood pressure cuff, electrocardiography and pulse oximeter will be applied. A 20-gauge Intravenous (IV) cannula will be inserted. Midazolam (1 mg) and fentanyl (50 µg) will be given IV. The patient will receive the designated block. Acetaminophen (15 mg/kg), will be infused IV slowly to be followed by acetated ringer infusion 6 mL/kg/hr. IV dexamethasone (8 mg) will be given. General anesthesia technique will be standardized in all patients. Anesthesia will be induced using fentanyl (2 microgram/kg), propofol (2.5 mg/kg), and atracurium (0.5 mg/kg) to facilitate endotracheal intubation (when the BIS scores drops to 40–60). All patients will be intubated and mechanically ventilated to maintain end-tidal carbon dioxide around 35 mmHg. Anesthesia will be maintained with isoflurane (in a 50% air-in-oxygen mixture) titrated to maintain BIS 40-60. Atracurium, 0.1 mg/kg supplements, will be given guided by train-of-four stimulation.Monitoring: electrocardiography, peripheral oxygen saturation (SpO2), ETCO2, Non-invasive blood pressure, bi-spectral index (BIS) and train of four monitors. For all patients, if BP and/or HR increased more than 15% from baseline‚ fentanyl, 0.5 mg/kg, will be given IV; if there was no response‚ another similar dose will be given, if still no response, nitroglycerin infusion will be started and titrated according to response. Hypotension‚will be managed with ephedrine 5 mg increments. Bradycardia will be managed with atropine 0.6 mg. To prevent nausea and vomiting, IV granisetron 1 mg will be administered.
Type of trial RCT
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 Treatment: Other
Anticipated trial start date 21/01/2024
Actual trial start date 18/01/2024
Anticipated date of last follow up 16/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Cervical Erector Spinae Plane Block versus Posterior Interscalene Brachial Plexus Block in Patients Undergoing Shoulder Arthroscopy
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 PIBP group 25 mL bupivacaine (0.25%) will then be injected in increments of 5 mL once The skin will be prepared with standard antiseptic and draping. Patients will be positioned in the lateral position. Bony landmarks will be identified before ultrasound imaging. A high frequency (4–12 MHz) linear-array ultrasound transducer covered with a sterile sheath will be applied to the skin at the level of C6. At the junction of the trapezius and levator scapulae muscles, 5 mL of lidocaine (2%) will be injected and 50-mm-long 22-gauge short bevel needle will be advanced toward the interscalene groove under direct ultrasound guidance. The needle will be guided using an in-plane ultrasound technique until the posterior aspect of the brachial plexus at the C5/C6 level is reached. The bevel of the needle will be turned laterally toward the shoulder. A bolus of 25 mL bupivacaine (0.25%) will then be injected in increments of 5 mL through the needle after negative aspiration to avoid intravascular injection. The duration of block performance will be recorded. 40 Active-Treatment of Control Group
Experimental Group ESP group 25 mL of 0.25% bupivacaine will be injected in 5 mls aliquots once For ESP group (40 patients), the skin will be prepared with standard antiseptic and draping. Patients will be positioned in the lateral position. A high frequency (4–12 MHz) linear-array ultrasound transducer covered with a sterile sheath will be applied to the skin in transverse orientation lateral to the posterior midline to identify the C7 TP, vertebral Artery, erector spinae muscle, and scalene muscle. Using an in-plane technique, a 90-mm-long 22-gauge needle will be inserted in a lateral-to-medial direction targeting the posterior tip of the C7 TP posterior tubercle. After negative aspiration, 25 mL of 0.25% bupivacaine will be injected in 5 mls aliquots. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients aged 18–65 years • American Society of Anesthesiologists (ASA) I or II • Scheduled for elective unilateral shoulder arthroscopy (rotator cuff repair, bankart repair, superior labral tear from anterior to posterior repair, and/or acromioplasty). • Coagulation Or bleeding disorder, anticoagulant therapy • Cervical disc issues, • Allergy/sensitivity to local anaesthetics and/or opioids, • Infection in the block area, • Contralateral hemidiaphragmatic paralysis, pneumonectomy or vocal cord palsy, severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea. • Pregnancy or suspected pregnancy, breast feeding mother, • Body mass index greater than 35 kg/m2, • Significant psychiatric or cognitive conditions interfering with assessment. • Unstable coronary artery disease, congestive heart failure, or arrhythmias. • Pre-existing neurological deficits or neuropathy affecting the brachial plexus. Cognitive or intellectual disability resulting in difficulty communicating with the care givers. • Pre-existing chronic pain or daily consumption of opioid analgesics. • Significant renal or hepatic impairment. • Refusal to participate • Block failure Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/11/2023 faculty of medicine menoufia university
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghaffar street shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time to first postoperative analgesia requirement. 24 hours
Secondary Outcome 2) Postoperative pain severity: in the recovery room, the severity of pain will be assessed using the VAS by study investigators as soon as the patient became alert enough to report pain, at PACU admission‚ every hour for the first 8 hours‚ then every 3 hours. The VAS of the postoperative pain will be recorded as static (during rest) and dynamic (during mobilization) measurements. 24 hours
Secondary Outcome Intraoperative Needs for nitroglycerin intraoperatively
Secondary Outcome Anesthetic requirements (ETiso) just before skin incision then envery 15 minutes till extubation. intraoperatively
Secondary Outcome Intraoperative (fentanyl) and postoperative (ibuprofen and meperidine) analgesic requirements. intraoperatively
Secondary Outcome Intraoperative mean arterial pressure (MAP), heart rate (HR). MAP and HR will be recorded before induction of anesthesia (baseline); immediately before the block; after skin incision; every 5 minutes intraoperatively; at PACU admission, PACU discharge and at 2, 4, 8, 12, and 24 hours postoperatively. preoperatively, intraoperatively and postoperatively
Secondary Outcome Patient discomfort during block performance > using a verbal rating scale (VRS) of 0 to 10. during block performance
Secondary Outcome 9) Aadverse effects (e.g., nausea, vomiting) and Block related complications Such as, block failure, upper limb motor function, LAST, dizziness, facial flushing, Pneumothorax, hypotension, phrenic nerve affection (diaphragmatic US assessment), hematoma, the side effects of the block (Horner’s syndrome, hoarseness, and subjective dyspnea, which can be caused by ipsilateral stellate ganglion, recurrent laryngeal nerve, and phrenic nerve block, respectively), pneumothorax (US assessment) and the procedural time (time between insertion and removal of the nerve-stimulating needle) will be recorded. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufia university hospitals 25 yassin abdelghaffar street shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors 25 yassin abdelghaffar street shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor anesthesia department faculty of medicine menoufia university 25 yassin abdelghaffar street shebin elkom 32511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 002048222304 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anestheisa
Role Name Email Phone Street address
Public Enquiries wesam sultan wesamsultan1@gmail.com 0020482228304 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries sabry abdallah sabryabdallah222@yahoo.com 0020482228304 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia
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 deidentification Study Protocol, Statistical Analysis Plan, Informed Consent form will be available Immediately following publication for Researchers who provide a methodologically sound proposal Informed Consent Form,Statistical Analysis Plan,Study Protocol from start till publication personal contact through sabryabdallah222@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
contact the public enquiries principle at wesamsultan1@gmail.com 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