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The objective of the current study is to compare the efficacy of the analgesic effect of ultrasound-guided unilateral Rhomboid intercostal and sub serratus plane block (RISS) versus Serratus anterior plane block (SAPB) in Thoracotomy incision.
Open thoracotomy is commonly considered to be one of the most agonizing surgical operations. Pain following thoracotomy greatly impedes patient recovery and postoperative respiration. The pain experienced after a thoracotomy can originate from various factors, including the surgical incision, injury to the ribs and intercostal nerves, manipulation of the pleura and lung tissue, and the placement of a drainage tube.Recent advances in regional anesthesia techniques have aimed to provide more targeted and effective pain relief. Among these, ultrasound-guided fascial plane blocks, such as the rhomboid intercostal sub-serratus plane (RISS) block and the serratus anterior plane (SAP) block, have emerged as promising options. Both blocks target the thoracic nerves, but they differ in their anatomical approach and potential analgesic effects Postoperative pain was not only related to a comfortable recovery but also related to postoperative complications including pulmonary dysfunction, so the management of postoperative pain is an important part of the care of post operation.
Regional anesthesia techniques have been shown to have a good effect on postoperative analgesia and helps patients gain early recovery after operation.
Serratus anterior plane block (SAPB) is an easy, and safe method used for blockade of the sensory plane of the lateral cutaneous branch of the intercostal nerve (T2-T9).
The Serratus anterior plane block targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax. These branches of the intercostal nerves travel through the two potential spaces described above.
The "Rhomboid intercostal and sub serratus plane block" (RISS) is a relatively newer block technique whose efficacy was documented in patients undergoing thoracic surgeries.
The RISS plane block involves the injection of local anesthetics into fascial planes, theoretically allowing for catheter placement to achieve continuous analgesia. Successful RISS plane blocks have been reported in various procedures, including lung transplantation, radical mastectomy, and nephrectomy, strongly suggesting favorable outcomes in postoperative pain relief.
In 2016, Elsharkawy et al. introduced a RA technique known as the rhomboid intercostal block (RIB). Rhomboid intercostal block involves injecting a local anesthetic into the upper intercostal muscle plane beneath the rhomboid muscles, providing analgesia to both the anterior and posterior thorax.Based on past studies, investigators found that RISS and SAPB are effectively decrease total opioid consumption, so investigators hypothesized one of them is the best.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 22(IBM Corp., Armonk, NY, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R | Experimental | A high- frequency linear ultrasound transducer will be placed longitudinally (in the sagittal plane) on the patient's back, just 2 cm medial to the medial scapular border. Then, the probe will be slightly rotated to obtain an oblique parasagittal plane. The following landmarks will be identified: the trapezius muscle, rhomboid major muscle, intercostal muscles, pleura, and lungs (from superficial to deep in order of appearance). The rhomboid major muscle will be distinguished at the level of the T6 and T7 vertebrae, below the trapezius muscle. |
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| Group S | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain | Drug | After the location will be confirmed through hydrodissection of 1 ml on the plane between the rhomboid major and the underlying intercostal muscles after confirming a negative aspiration via a a 22-gauge short bevel sonovisible needle (Spinocan, B. Braun Melsungen AG, Germany) using an in-plane technique then 10 ml of bupivacaine (concentration 0.25%) will be injected. and its spread will be manifested by the hydrodissection and widening of the plane visualized by ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | in microgram | 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Total intraoperative opioid consumption | in microgram | from begining of operation till 5 minutes after extubation |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain |
| Measure | Description | Time Frame |
|---|---|---|
| Age | in years | 5 minutes before entering operation department |
| Sex | Male of female | 5 minutes before entering operation department |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emad El Mohamed Abd El-Razek, M.Sc. | Contact | 0 109 400 6418 | +2 | ema18@fayoum.edu.eg |
| Yasser S Mostafa, MD | Contact | 01010509735 | +2 | ysm03@fayoum.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mahdy A Abdelhady, MD | Fayoum University | Study Chair |
| Mohamed A Hamed, MD | Fayoum University | Principal Investigator |
| Mina M Sobhy, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University hospital | Recruiting | El Fayoum Qesm | Faiyum Governorate | 63514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32079739 | Background | Altiparmak B, Korkmaz Toker M, Uysal AI, Dere O, Ugur B. Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia in breast cancer surgery: a prospective, randomized controlled trial. Reg Anesth Pain Med. 2020 Apr;45(4):277-282. doi: 10.1136/rapm-2019-101114. Epub 2020 Feb 19. | |
| 31668692 | Background |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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After endotracheal intubation, just before the block, the patients were randomly allocated into two groups based on a computerized randomization table created by a researcher who was not involved in the study. The researcher assigned a random ID to each patient, and a blinded anesthesiologist used this ID while collecting the postoperative data in the surgical ward.
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Triple (Participant, Care Provider, Outcomes Assessor) Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.
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| Ultrasound | Device | A linear US transducer (Phillips-Saronno Italy) was placed vertically 3 cm lateral to the midline to visualize back muscles: the trapezius above, the rhomboid major in the middle, and the erector-spinae muscle on the bottom, as well as the TPs with shimmering pleura in between. |
|
| Immediately after the procedures |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | Immediately after the procedures |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain | 1 hour postoperatively. |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | 1 hour postoperatively. |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain | 3 hours postoperatively. |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | 3 hours postoperatively. |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain | 6 hours postoperatively. |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | 6 hours postoperatively. |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain | 12 hours postoperatively. |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | 12 hours postoperatively. |
| Visual analog pain score at rest | Ranging from 0 indicating no pain to 10 indicating extreme pain | 24 hours postoperatively. |
| Visual analog pain score at cough | Ranging from 0 indicating no pain to 10 indicating extreme pain | 24 hours postoperatively. |
| Time of first rescue analgesic | in minutes | 5 minutes before first analgesic request |
| Baseline Heart rate | Beat / minute | 5 minutes before anesthesia |
| Intraoperative Heart rate | Beat / minute | every 30 minutes along operation |
| Baseline mean arterial blood pressure | mmHg | 5 minutes before anesthesia |
| Intraoperative mean arterial blood pressure | mmHg | every 30 minutes along operation |
| Baseline oxygen saturation | percentage with pulse oximetry | 5 minutes before anesthesia |
| Intraoperative oxygen saturation | percentage with pulse oximetry | every 30 minutes along operation |
| Total length of stay in hospital | in days | 1-2 days |
| Patient satisfaction score | 5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied | 12 hours after end of operation and extubation |
| Incidence of hematoma | Yes or no | 30 minutes after nerve block |
| Incidence of local anesthetic toxicity | Yes or no | 30 minutes after nerve block |
| Incidence of nausea | Yes or no | 24 hours postoperative |
| Incidence of vomiting | Yes or no | 24 hours postoperative |
| Ramsay sedation score | From 1 to 5 (1 Awake; agitated or restless or both - 2 Awake; cooperative, oriented, and tranquil - 3 Awake but responds to commands only - 4 Asleep; brisk response to light glabellar tap or loud auditory stimulus - 5 Asleep; sluggish response to light glabellar tap or loud auditory stimulus) Asleep; no response to glabellar tap or loud auditory stimulus | 24 hours postoperative |
| Fayoum University |
| Study Director |
| Longo F, Piliego C. Rhomboid intercostal and subserratus plane block for non-intubated video-assisted thoracoscopic surgery. J Clin Anesth. 2020 May;61:109612. doi: 10.1016/j.jclinane.2019.09.006. Epub 2019 Oct 24. No abstract available. |
| 35359482 | Background | Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24. |
| D000588 |
| Amines |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |