Clinical trial NCT05691920: Regional Blocks for CABG Artery Bypass Graft Surgery
Official title: Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Analgesia After Coronary Artery Bypass Graft Surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing CABG surgery

Exclusion Criteria:

* BMI above 40
* allergy for drugs used
* complicated cases
* patient refusal
* chronic opioid use
* cognitive dysfunction
* chronic kidney disease

Primary outcomes:
measure: Postoperative fentanyl requirements for 24 hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Visual analogue score
timeFrame: 24 hours postoperatively
measure: Rescue analgesia
timeFrame: 24 hours postoperatively
measure: Side effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.