Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242431
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-01-08
Brief Title:
Effects of Serratus Posterior Superior Intercostal Plane Block and Pectoralis Nerve Block in Coronary Artery Surgery
Sponsor:
Hitit University
Organization:
Hitit University
Study Overview
Official Title:
Comparison of Serratus Posterior Superior Intercostal Plane Block SPSIPB and Pectoralis Nerve Block PECS-II Applications in The Treatment of Acute Pain After Coronary Artery Bypass Surgery CABG
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in all types of chest surgery particularly coronary artery bypass graft CABG surgery Patients with high levels of pain who cannot breathe effectively may experience atelectasis cardiac ischemia and arrhythmias This prolongs hospitalization and increases the frequency of postoperative pulmonary complications and morbidity If postoperative acute pain is not adequately treated it may lead to the development of chronic pain hindering patients from recovering normal activities for an extended period In addition to medications various neuroaxial and peripheral nerve blocks can be used in cardiac surgery
The use of high-dose heparin during surgery along with neuroaxial anesthesia thoracic epidural and intrathecal opioids is controversial Thoracic paravertebral block TPVB has demonstrated efficacy and is considered a method with fewer potential side effects compared to thoracic epidural anesthesia However TPVB has become less preferred in cardiac surgery due to its sympathetic blockade Recently peripheral nerve blocks have gained popularity as alternatives These blocks include pectoralis nerve blocks PECS-I PECS-II serratus anterior plane block SAPB serratus posterior superior intercostal plane block SPSIPB erector spinae plane block ESPB transverse thoracic plane blocks TTMP pectointercostal-fascial blocks PIF and intercostal nerve blocks These blocks are newer and more superficially located compared to TPVB Additionally these fascial blocks are considered safer in terms of side effects as they do not cause sympathetic blockade like TPVB
The hypothesis of this study is that SPSIPB can provide more extensive dermatomal analgesia compared to PECS-II resulting in more effective postoperative analgesia Therefore this study plans to compare the analgesic effects of ultrasound-guided SPSIPB and PECS-II block applications in patients undergoing coronary artery bypass surgery with sternotomy
The use of high-dose heparin during surgery along with neuroaxial anesthesia thoracic epidural and intrathecal opioids is controversial Thoracic paravertebral block TPVB has demonstrated efficacy and is considered a method with fewer potential side effects compared to thoracic epidural anesthesia However TPVB has become less preferred in cardiac surgery due to its sympathetic blockade Recently peripheral nerve blocks have gained popularity as alternatives These blocks include pectoralis nerve blocks PECS-I PECS-II serratus anterior plane block SAPB serratus posterior superior intercostal plane block SPSIPB erector spinae plane block ESPB transverse thoracic plane blocks TTMP pectointercostal-fascial blocks PIF and intercostal nerve blocks These blocks are newer and more superficially located compared to TPVB Additionally these fascial blocks are considered safer in terms of side effects as they do not cause sympathetic blockade like TPVB
The hypothesis of this study is that SPSIPB can provide more extensive dermatomal analgesia compared to PECS-II resulting in more effective postoperative analgesia Therefore this study plans to compare the analgesic effects of ultrasound-guided SPSIPB and PECS-II block applications in patients undergoing coronary artery bypass surgery with sternotomy
Detailed Description:
In many open cardiovascular operations median sternotomy remains the most commonly used incision method due to its excellent visibility This incision made at the midline of the sternum is frequently employed in open cardiovascular surgeries resection of anterior mediastinal masses radical thymectomies and dissection of the superior mediastinum The patient is placed in a supine position and an incision is made at the midline of the sternum starting from the jugular notch and extending to 1-2 cm below the xiphoid ending on the linea alba After passing through the subcutaneous tissue with an electrocautery the anterior sternal fascia is reached as there is no muscle tissue in the midline immediately after subcutaneous passage Upon passing through the subcutaneous tissue with an electrocautery in the jugulum region the clavicular heads of the clavioclavicular ligament connecting the manubriums undersurface can be palpated This ligament is cut and opened using electrocautery The posterior surface of the sternum is dissected and separated from mediastinal structures by blunt dissections starting from the posterior jugulum and below the xiphoid using fingers Subsequently the midline of the sternum is marked with an electrocautery An automatic saw is placed from the jugulum to the posterior surface of the sternum and it is cut upwards slightly to avoid injuring the structures behind the sternum along the midline After gentle retraction the edges of the periosteum are cauterized at periosteal bleeding points and hemostasis is achieved by applying bone wax The sternal retractor is placed on the lower 23 of the sternum minimizing the risk of occult fractures neurological deficit and damage to the innominate vein due to excessive tension on the superior costae As the sternal retractor is slowly opened access to the mediastinum is gained Before closing the sternum at the end of the surgery one or two chest tubes should be placed in the mediastinum or pleural spaces depending on the need for drainage When closing the sternum 4-7 thick stainless steel wires no5-6 are used individually or in a crossed manner to be securely fastened by tightly bending the wire ends at the midline and the joined end is buried in the sternal tissue Pectoral fascia and subcutaneous tissue are closed with absorbable sutures Tight closure of the fascia on the sternum is crucial to prevent external contamination infection or clot collection Postoperative pain after cardiac surgery is highly focused Sternotomy sternal retraction internal mammary artery dissection posterior rib dislocation or fracture possible brachial plexus injury mediastinal and pleural drains saphenous vein damage all contribute to postoperative pain In some patients if the lateral decubitus position is required position-related pain may develop in the shoulder joint There is also a change in pain modulation in the peripheral and central nervous systems during the postoperative period Opioid-based analgesia is associated with negative effects such as nausea vomiting sedation urinary retention itching respiratory depression and delayed extubation Another analgesia method is the application of a thoracic epidural catheter Thoracic epidural analgesia TEA can provide excellent opioid-free analgesia after cardiac surgery and is associated with a reduction in respiratory complications arrhythmias and mortality However in TEA there is an increased risk of developing epidural hematoma during the perioperative period compared to non-cardiac surgeries due to the use of anticoagulant and antiplatelet agents in planned cardiac surgeries Analgesia provided by serratus anterior plane block and pectoral muscle plane block does not cover the midline sternotomy pain However ultrasound-guided serratus posterior superior block SPSPB is a new interfascial plane block that has started to be routinely used for analgesia after invasive operations such as sternotomy It relies on the injection above the serratus posterior superior muscle at the level of the 2nd or 3rd rib This block provides analgesia in conditions such as interscapular pain chronic myofascial pain syndromes scapulocostal syndrome and shoulder pain The serratus posterior superior SPS muscle is located at the C7-T2 level and attaches to the lateral edges of the second and fifth ribs It is innervated by the lower cervical and upper intercostal nerves Analgesia is achieved by blocking these nerves with SPS block In a cadaver study observed that the spread of SPSPB was staining only in the 7-10th intercostal levels on the surface fascia of the trapezius muscle on the left side without staining on the right side There was also significant staining deep in the trapezius muscle on both sides Romboid major was distinctly stained both superficially and deeply while romboid minor was only deep-stained Therefore SPSPB will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain breast surgery chest surgery sternotomy Another highly effective regional anesthesia method with high postoperative analgesic efficacy after breast and sternotomy surgeries is pectoral blocks Pectoral block PECS block was described as an alternative to paravertebral and epidural blocks for pain control after surgery in patients undergoing breast surgery PECS block has two types Type I is performed between the pectoralis major and minor with local anesthetic and can be applied in the placement of subpectoral prosthesis with breast expander PECS Block Type II is an injection of local anesthetic between pectoralis minor and serratus anterior muscles in addition to PECS Block Type I PECS Type II block is one of the regional anesthesia techniques routinely used for postoperative analgesia in sternotomy mastectomy and axillary lymph node excision Despite being a regional and superficial block PECS block is highly reliable and easy to apply in terms of side effects Both SPSPB and PECS II block are peripheral block applications that are quite popular effective and routinely used in clinical practice for postoperative analgesia in surgeries such as sternotomy and mastectomy in the field of anesthesiology
There is currently no study in the literature comparing SPSPB and PECS type 2 block for post-thoracotomy analgesia The hypothesis of this study is that SPSIPB can provide more extensive dermatomal analgesia compared to PECS-II resulting in more effective postoperative analgesia Therefore this study plans to compare and evaluate the analgesic effects of ultrasound-guided SPSIPB and PECS-II block applications in patients undergoing coronary artery bypass surgery with sternotomy
There is currently no study in the literature comparing SPSPB and PECS type 2 block for post-thoracotomy analgesia The hypothesis of this study is that SPSIPB can provide more extensive dermatomal analgesia compared to PECS-II resulting in more effective postoperative analgesia Therefore this study plans to compare and evaluate the analgesic effects of ultrasound-guided SPSIPB and PECS-II block applications in patients undergoing coronary artery bypass surgery with sternotomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None