Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
Location contact
Mohamed A Hamed, MD.
CONTACT
010105093736 ext. +20
Yasser S Mostafa, M.D.
CONTACT
1010509735 ext. +20
NCT Number: NCT06856538
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
El Fayoum Qesm, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
Mohamed A Hamed, MD.
CONTACT
010105093736 ext. +20
Yasser S Mostafa, M.D.
CONTACT
1010509735 ext. +20
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Marcaine 0.25%
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.
Time frame: 24 hours postoperatively.
in microgram
Time frame: from begining of operation till 5 minutes after extubation
in microgram
Time frame: Immediately after the procedures
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: Immediately after the procedures
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 1 hour postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 1 hour postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 3 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 3 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 6 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 6 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 12 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 12 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 24 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 24 hours postoperatively.
Ranging from 0 indicating no pain to 10 indicating extreme pain
Time frame: 5 minutes before first analgesic request
in minutes
Time frame: 5 minutes before anesthesia
Beat / minute
Time frame: every 30 minutes along operation
Beat / minute
Time frame: 5 minutes before anesthesia
mmHg
Time frame: every 30 minutes along operation
mmHg
Time frame: 5 minutes before anesthesia
percentage with pulse oximetry
Time frame: every 30 minutes along operation
percentage with pulse oximetry
Time frame: 1-2 days
in days
Time frame: 12 hours after end of operation and extubation
5 degree Likeart scale where 1 Extremely satisfied to 5 Extremely not satisfied
Time frame: 30 minutes after nerve block
Yes or no
Time frame: 30 minutes after nerve block
Yes or no
Time frame: 24 hours postoperative
Yes or no
Time frame: 24 hours postoperative
Yes or no
Time frame: 24 hours postoperative
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
Time frame: 5 minutes before entering operation department
in years
Time frame: 5 minutes before entering operation department
Male of female
Contact information is provided by the study sponsor or research team.
Emad El Mohamed Abd El-Razek, M.Sc.
CONTACT
0 109 400 6418 ext. +2
Yasser S Mostafa, MD
CONTACT
01010509735 ext. +2
Yasser S Mostafa, MD
Other
Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal Sub Serratus Plane Block Versus Serratus Anterior Plane Block With General Anesthesia in Thoracotomy
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