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.: PACTR202402482417482 Date of Approval: 01/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesia after abdominal exploration surgeries
Official scientific title Analgesic Efficacy of Single versus Double Level Erector Spinae Plane Block in Patients Undergoing Midline Laparotomy: A Prospective Randomized Clinical Trial
Brief summary describing the background and objectives of the trial It is increasingly recognized that in recovery from major surgery, the trio of effective pain relief, early mobilization, and early recovery of gastrointestinal function is crucial. These components of recovery are inextricably linked and if we are to gain maximum benefit for our patients from effective analgesia, then these other factors must also be addressed and achieved. It will be apparent from this that while good analgesia will aid recovery, side-effects from analgesia have the potential to obstruct this process. This would include limiting mobility by having patients attached to pumps and monitors, need for admitting the patient to high dependency unit, risk of lower limb motor weakness or paresthesia, associated with the analgesic technique which is often a particular issue for patients receiving epidural analgesia. It also includes side effects of systemically administered analgesics like renal impairment, coagulopathy, gastric upset with nonsteroidal anti inflammatory drugs and respiratory depression, immunosuppression with associated risk of cancer recurrence, impaired bowel motility and habituation and addiction risks with opioids. Pain after laparotomy consists of both visceral pain and somatic pain from the abdominal wall. The visceral pain is conducted to the spinal cord through the sympathetic chain, whereas somatic pain is conducted through the T7–L1 spinal nerves. TEA and paravertebral blocks are advantageous in that they can provide both visceral and somatic analgesia; however, these techniques are technically difficult to perform and have a relatively high risk of complications. In this study we aim to compare the intraoperative and postoperative analgesic efficacy of ultrasound guided single level ESP block versus bilevel ESP block in patients undergoing midline laparotomy.
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 21/05/2024
Anticipated date of last follow up 26/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Single versus Double Level Erector Spinae Plane Block in Patients Undergoing Midline Laparotomy
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 SL ESP 30 mL of bupivacaine 0.25% plus 4 mg dexamethasone once For SL ESP group, after shifting the patient to the lateral position and skin sterilization, the block will be performed at the level of T8. Counting down from the spine of the seventh cervical vertebrae, and the spine of the 9 thoracic vertebrae (T9). A linear high-frequency (4-12 MHz) ultrasound transducer (SonoSite M-Turbo; FUJIFILM Sonosite, Inc., Bothell, WA) will be placed sagittal 3 cm lateral to T9 spinous process. A hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge short bevel needle (Spinocan; B. Braun Melsungen AG, Melsungen, Germany) will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. When the appropriate needle tip is confirmed, 30 mL of bupivacaine 0.25% plus 4 mg dexamethasone will be injected. The procedure will be repeated following the same steps on the other side of the back. Sonographic confirmation of the local anesthetic spread will be seen as an anechoic shadow in the paravertebral spaces. Intraoperatively, if blood pressure and/or heart rate 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. To prevent nausea and vomiting, IV granisetron 1 mg will be administered. Toward the end of surgery, acetaminophen (15 mg/kg) will be infused slowly (over 15 minutes) to end before skin suturing and to be given postoperatively 8 hourly. Residual muscle relaxation will be reversed with neostigmine 50 μg/kg IV and atropine 10 μg/kg IV. At the end of the surgical procedure, patients will be extubated and transferred to the postanesthesia care unit (PACU) to be 25 Active-Treatment of Control Group
Experimental Group DL ESP 30 mL of bupivacaine 0.25% plus 4 mg dexamethasone once On arrival to the operative room, the anesthesiologist responsible for administering the block from the researcher anesthesia team will open the envelope. ESP block will be performed by the same anesthetist who is experienced enough in US guided regional blocks. A 20 gauge Intravenous (IV) cannula will be inserted, acetaminophen 15 mg/kg, will be infused 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 entropy 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 sevoflurane (in a 50% air-in-oxygen mixture) titrated to maintain response entropy and state entropy 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, entropy and train of four monitors. After the induction of anaesthesia and before surgery, an ultrasound-guided ESP block will be performed in lateral position. For DL ESP group, the injectate will be divided into 2 halves (15 mls each), the same technique will be followed with one half of the injectate given at T7 and the other half at T10. The procedure will be repeated following the same steps on the other side of the back. Sonographic confirmation of the local anesthetic spread will be seen as an anechoic shadow in the paravertebral spaces. Intraoperatively, if blood pressure and/or heart rate 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 res 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All patients within the age range of 18 to 65 years old. • American Society of Anesthesiologists physical status classes I or II. • Scheduled for midline laparotomy. • Refusal of the patient to give informed consent. • Allergy or contraindication to any of the study drugs. • Renal, cardiovascular, central nervous system, respiratory, gastrointestinal diseases. • Infection at the block site. • Fibromyalgia, chronic pain and those taking opioid analgesics. 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 15/11/2023 faculty of medicine menoufia university egypt ethics and research commitee
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 postoperative pain intensity using Visual Analog Scale (VAS) score. The VAS of the postoperative pain will be recorded as static (during rest) and dynamic (during forceful cough) measurements. 1,2,3,4,5,6,7,8, 10,12,14,16,18,20,22,24
Secondary Outcome Time to first postoperative analgesia requirement (minutes) postoperatively
Secondary Outcome Intraoperative fentanyl (mic) and postoperative (ibuprofen and morphine) (mg) analgesic requirements. 24 hours
Secondary Outcome Mean arterial pressure and heart rate 2, 4, 8, 12, and 24 hours postoperatively
Secondary Outcome Adverse effects (e.g., nausea, vomiting, Itching), patient satisfaction and Block related complications Such as, block failure (VAS ≥7 at PACU admission), LAST, dizziness, hypotension, were recorded. postoperatively
Secondary Outcome Overall patient satisfaction at the end of 24 hours postoperatively: all patients will be asked to rate the overall degree of satisfaction of analgesia using a 1 to 3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) 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
Primary Sponsor anesthesia departement school 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 0020482228304 25b yassin abdekghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries sabry abdallah sabryabdallah222@yahoo.com 0020482228304 25 yassin abdelghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia
Role Name Email Phone Street address
Scientific Enquiries wesam sultan wesamsultan1@gmail.com 0020482228304 25 yassin abdelghaffar
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 all though statistical analysis and manuscript preparation till publication review commitee identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
contact the principle investigator through khgaballah@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