Back to resultsUltrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rhomboid intercostal subserratus plane block
Erector spinae plane block
Thoraccic Epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Rhomboid intercostal block
Eligibility Criteria
Inclusion Criteria: Type of surgery; open nephrectomy. Physical status ASA II, III. Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2. Exclusion Criteria: Patient refusal. Local infection at the puncture site. Severe respiratory or cardiac disorders. Advanced liver or kidney disease. History of psychological disorders and/or chronic pain. Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. Patients with known sensitivity or contraindication to amide local anesthetics used in the study.
Sites / Locations
- National Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Erector spinae block
Rhomboid intercostal block
Thoracic epidural analgesia
Arm Description
Under strict aseptic precautions, we will begin the scout scan with a high-frequency (6-12 MHz) linear US probe placed parasagitally in cephalocaudal orientation adjacent to C7 spinous process and the first rib will be identified with ultrasound. Then, we can directly count the ribs and come down to desired level of ribs or corresponding transverse process (the 8th thoracic spinous process). Once located, erector spinae and trapezius muscles will be identified overlying it. The skin will be infiltrated by 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane in the cranio-caudal direction. When the needle contacted the transverse process, 1 ml normal saline will be injected to confirm correct needle placement by visualizing the linear pattern of hydrodissection. After aspiration, 30 ml bupivacaine 0.25% will be injected.
While the patient in the sitting position, the 5th thoracic spinous process can be identified, a high-frequency (6-12 MHz) linear US probe will be placed in the sagittal plane medial to the medial border of the scapula and then rotated to be 1 to 2 cm medial to the medial scapular border. The plane between the rhomboid major and the intercostal muscles will be identified. 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane from a superomedial to an inferolateral direction then 15 ml of bupivacaine 0.25% will be administered (at the T5 level). Then the probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and the external intercostal muscle at the T8 level. The needle will be directed caudally and laterally beyond the inferior angle of the scapula. 15 ml of bupivacaine 0.25% will be administered.
While the patient in the sitting position, the T7-T8 interspace can be identified. Then, skin infiltration with 2 ml of 1% lidocaine will be performed. Then, an 18-G Tuohy needle with a 20-G catheter (Perifix®, B.Braun, Germany) will be inserted through, and the epidural space will be located using the loss of resistance approach, then the patient will be given (5-10 mL) of bupivacaine 0.25% and rested into the supine position.
Outcomes
Primary Outcome Measures
The total amount of morphine consumption in (mg)
amount of morphine in mg consumed in 1st 24 hours
Secondary Outcome Measures
Time of first request of analgesia
calculated from the time of complete injection of local anesthetics till the numerical pain rating scale (NRS) is ≥3.(NRS requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable)
Total amount fentanyl in (microgram)
total amount of intraoperative fentanyl consumed in micrograms
Change in heart rate in (beat/min)
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
Change in mean arterial blood pressure in (mmHg)
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
Numeric Pain Rating Scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Nausea and vomiting Scores
Nausea and vomiting Scores using a four-point verbal scale. (None =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting >one
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05822011
Brief Title
Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy
Official Title
Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block Versus Erector Spinae Plane Block in Open Nephrectomy. Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our aim is to measure the efficacy of rhomboid intercostal subserratus plane block and erector spinae plane block in comparison to thoracic epidural block in patients undergoing open nephrectomy
Detailed Description
Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction. Rhomboid intercostal subserratus plane block (RISS) is considered a novel approach for chest wall and upper abdominal analgesia, initially showed promising results, first reported in 2016. Erector Spinae Plane block (ESB), was initially described in 2016 for analgesia in thoracic neuropathic pain. It has also been widely used in both adults and children at different levels for different indications. Epidural analgesia is the gold standard for perioperative analgesia in open surgery. Epidural analgesia-related significant complications can include epidural hematoma, postoperative neurologic deficit, and post-dural puncture headache, and anesthesiologists are searching for alternative analgesic modalities that have adequate analgesia and a lower complication risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Rhomboid intercostal block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erector spinae block
Arm Type
Active Comparator
Arm Description
Under strict aseptic precautions, we will begin the scout scan with a high-frequency (6-12 MHz) linear US probe placed parasagitally in cephalocaudal orientation adjacent to C7 spinous process and the first rib will be identified with ultrasound. Then, we can directly count the ribs and come down to desired level of ribs or corresponding transverse process (the 8th thoracic spinous process). Once located, erector spinae and trapezius muscles will be identified overlying it. The skin will be infiltrated by 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane in the cranio-caudal direction. When the needle contacted the transverse process, 1 ml normal saline will be injected to confirm correct needle placement by visualizing the linear pattern of hydrodissection. After aspiration, 30 ml bupivacaine 0.25% will be injected.
Arm Title
Rhomboid intercostal block
Arm Type
Active Comparator
Arm Description
While the patient in the sitting position, the 5th thoracic spinous process can be identified, a high-frequency (6-12 MHz) linear US probe will be placed in the sagittal plane medial to the medial border of the scapula and then rotated to be 1 to 2 cm medial to the medial scapular border. The plane between the rhomboid major and the intercostal muscles will be identified. 2 ml of lidocaine 1% subcutaneously and a 22- gauge, 80 mm needle (Stimuplex D, B-Braun, Germany) will be advanced in plane from a superomedial to an inferolateral direction then 15 ml of bupivacaine 0.25% will be administered (at the T5 level). Then the probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and the external intercostal muscle at the T8 level. The needle will be directed caudally and laterally beyond the inferior angle of the scapula. 15 ml of bupivacaine 0.25% will be administered.
Arm Title
Thoracic epidural analgesia
Arm Type
Active Comparator
Arm Description
While the patient in the sitting position, the T7-T8 interspace can be identified. Then, skin infiltration with 2 ml of 1% lidocaine will be performed. Then, an 18-G Tuohy needle with a 20-G catheter (Perifix®, B.Braun, Germany) will be inserted through, and the epidural space will be located using the loss of resistance approach, then the patient will be given (5-10 mL) of bupivacaine 0.25% and rested into the supine position.
Intervention Type
Procedure
Intervention Name(s)
Rhomboid intercostal subserratus plane block
Other Intervention Name(s)
RISS
Intervention Description
Fascial plane block
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ESB
Intervention Description
Fascial plane block
Intervention Type
Procedure
Intervention Name(s)
Thoraccic Epidural analgesia
Other Intervention Name(s)
TEA
Intervention Description
Neuroaxial block
Primary Outcome Measure Information:
Title
The total amount of morphine consumption in (mg)
Description
amount of morphine in mg consumed in 1st 24 hours
Time Frame
first 24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Time of first request of analgesia
Description
calculated from the time of complete injection of local anesthetics till the numerical pain rating scale (NRS) is ≥3.(NRS requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable)
Time Frame
first 24 hours postoperatively
Title
Total amount fentanyl in (microgram)
Description
total amount of intraoperative fentanyl consumed in micrograms
Time Frame
intra operative duration
Title
Change in heart rate in (beat/min)
Description
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
Time Frame
From just before induction till 24 hours post operatively
Title
Change in mean arterial blood pressure in (mmHg)
Description
Readings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
Time Frame
From just before induction till 24 hours post operatively
Title
Numeric Pain Rating Scale
Description
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Time Frame
first 24 hours postoperatively
Title
Nausea and vomiting Scores
Description
Nausea and vomiting Scores using a four-point verbal scale. (None =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting >one
Time Frame
first 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type of surgery; open nephrectomy.
Physical status ASA II, III.
Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2.
Exclusion Criteria:
Patient refusal.
Local infection at the puncture site.
Severe respiratory or cardiac disorders.
Advanced liver or kidney disease.
History of psychological disorders and/or chronic pain.
Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
Patients with known sensitivity or contraindication to amide local anesthetics used in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ma saad, Ass Lecturer
Phone
01229781573
Email
abosaaddr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa Al Youssef, Ass Prof
Phone
01007798466
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Al Awad, Professor
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
31727523
Citation
Bravi CA, Larcher A, Capitanio U, Mari A, Antonelli A, Artibani W, Barale M, Bertini R, Bove P, Brunocilla E, Da Pozzo L, Di Maida F, Fiori C, Gontero P, Li Marzi V, Longo N, Mirone V, Montanari E, Porpiglia F, Schiavina R, Schips L, Simeone C, Siracusano S, Terrone C, Trombetta C, Volpe A, Montorsi F, Ficarra V, Carini M, Minervini A. Perioperative Outcomes of Open, Laparoscopic, and Robotic Partial Nephrectomy: A Prospective Multicenter Observational Study (The RECORd 2 Project). Eur Urol Focus. 2021 Mar;7(2):390-396. doi: 10.1016/j.euf.2019.10.013. Epub 2019 Nov 12.
Results Reference
background
PubMed Identifier
33762197
Citation
Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
Results Reference
background
PubMed Identifier
24961586
Citation
Kang XH, Bao FP, Xiong XX, Li M, Jin TT, Shao J, Zhu SM. Major complications of epidural anesthesia: a prospective study of 5083 cases at a single hospital. Acta Anaesthesiol Scand. 2014 Aug;58(7):858-66. doi: 10.1111/aas.12360. Epub 2014 Jun 24.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
28188621
Citation
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Results Reference
background
PubMed Identifier
28625453
Citation
Ueshima H, Otake H. RETRACTED: Erector spinae plane block provides effective pain management during pneumothorax surgery. J Clin Anesth. 2017 Aug;40:74. doi: 10.1016/j.jclinane.2017.04.016. Epub 2017 Apr 28. No abstract available.
Results Reference
background
PubMed Identifier
28272292
Citation
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
Results Reference
background
PubMed Identifier
35030493
Citation
Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647. doi: 10.1016/j.jclinane.2022.110647. Epub 2022 Jan 11.
Results Reference
background
PubMed Identifier
30169476
Citation
Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.
Results Reference
background
PubMed Identifier
27291611
Citation
Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
Results Reference
background
PubMed Identifier
30640671
Citation
Elsharkawy H, Pawa A, Mariano ER. Reply to Dr Price: Interfascial plane blocks - a Time to Pause. Reg Anesth Pain Med. 2019 Jan;44(1):138. doi: 10.1136/rapm-2018-100020. Epub 2018 Dec 19. No abstract available.
Results Reference
background
PubMed Identifier
31998046
Citation
Sharma SK, Mistry T, Ahmed S. Ultrasound-guided thoracic erector spinae plane block: A modified transverse approach. Saudi J Anaesth. 2020 Jan-Mar;14(1):142-143. doi: 10.4103/sja.SJA_624_19. Epub 2020 Jan 6. No abstract available.
Results Reference
background
PubMed Identifier
32046475
Citation
Elsharkawy H, Hamadnalla H, Altinpulluk EY, Gabriel RA. Rhomboid intercostal and subserratus plane block -a case series. Korean J Anesthesiol. 2020 Dec;73(6):550-556. doi: 10.4097/kja.19479. Epub 2020 Feb 12.
Results Reference
background
PubMed Identifier
25432552
Citation
Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good reasons to practice ultrasound in critical care. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):323-35. doi: 10.5603/AIT.2014.0056.
Results Reference
background
PubMed Identifier
11883387
Citation
Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.
Results Reference
background
PubMed Identifier
32171499
Citation
Sakae TM, Yamauchi LHI, Takaschima AKK, Brandao JC, Benedetti RH. [Comparison between erector spinal plane block and epidural block techniques for postoperative analgesia in open cholecystectomies: a randomized clinical trial]. Braz J Anesthesiol. 2020 Jan-Feb;70(1):22-27. doi: 10.1016/j.bjan.2019.12.009. Epub 2020 Feb 27.
Results Reference
background
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Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy
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