A Phase 3 interventional study of Pectointercostal plane block and external oblique intercostal plane block and Fentanyl infusion in Analgesia After Coronary Artery Bypass Graft Surgery, sponsored by Alexandria University. Status unknown. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Alexandria University · Phase 3, Interventional, and Treatment
Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Procedure: Pectointercostal plane block and external oblique intercostal plane block
Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h
Procedure: Fentanyl infusion
Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks
Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h
Postoperative fentanyl requirements for 24 hours
Visual analogue score will be measured every 2 hours
Time frame: 24 hours postoperatively
Visual analogue score
Visual analogue score will be measured every 2 hours
Time frame: 24 hours postoperatively
Rescue analgesia
0.5 microgram/kg fentanyl will be given if visual analogue score more than 4
Time frame: 24 hours postoperatively
Side effects
Any side effect related to fentanyl or block technique will be detected and treated properly
Time frame: 24 hours postoperatively
No study locations are listed for this record.
Plan to share: Yes — Data will be shared on request
Supporting information: Study protocol, Csr
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alexandria University