- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07321639
Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy
Comparison of the Effectiveness of Ultrasound-Guided Recto-Intercostal Fascial Plane Block and Transversus Abdominis Plane Block in Postoperative Analgesia Management of Patients Undergoing Laparoscopic Cholecystectomy
Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery.
Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy.
This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.
Study Overview
Status
Detailed Description
Laparoscopic cholecystectomy is one of the most commonly performed abdominal surgical procedures. Postoperative pain after laparoscopic cholecystectomy is multifactorial and may result from trocar site incisions, visceral manipulation, peritoneal irritation, and diaphragmatic stimulation due to pneumoperitoneum. Various analgesic strategies, including systemic opioids, non-opioid analgesics, local anesthetic infiltration, and regional anesthesia techniques, are used to manage postoperative pain in these patients.
Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described regional anesthesia technique that provides analgesia to the sternal, epigastric, and upper-mid abdominal regions by targeting the fascial plane between the rectus abdominis muscle and the costal cartilage. RIFPB provides sensory blockade at the T6-T10/11 dermatomal levels and has been reported to be effective for postoperative analgesia in thoracic and upper abdominal procedures. Due to its anatomical spread and mechanism of action, RIFPB may offer effective analgesia following laparoscopic cholecystectomy.
Ultrasound-guided transversus abdominis plane block (TAPB) is a well-established regional anesthesia technique performed by injecting local anesthetic between the internal oblique and transversus abdominis muscles. TAPB provides analgesia to the anterolateral abdominal wall at the T6-L1 dermatomal levels and is commonly used for postoperative pain control after various abdominal surgeries, including laparoscopic cholecystectomy.
In this study, the investigators aim to compare the effectiveness of US-guided RIFPB and TAPB for postoperative pain management after laparoscopic cholecystectomy and to compare both techniques with a control group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayse Ince, Assist Prof
- Phone Number: 00905366774988
- Email: drayseince@gmail.com
Study Contact Backup
- Name: Tumay Uludag Yanaral, Assoc Prof
- Phone Number: 000905052422100
- Email: uludagt@yahoo.com
Study Locations
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-
-
Istanbul, Turkey (Türkiye)
- Istanbul Medipol University
-
Contact:
- Ayse Ince, Assist Prof
- Phone Number: 00905366774988
- Email: drayseince@gmail.com
-
Contact:
- Tumay Uludağ Yanaral, Assos Prof
- Phone Number: 000905052422100
- Email: uludagt@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
Exclusion Criteria:
- Known allergy to local anesthetics or opioid medications
- Infection at the planned block site
- History of alcohol or drug dependence
- Use of anticoagulant therapy
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Recto-intercostal fascial plane block
RIFP block will be performed, and standard postoperative pain management protocols will be applied.
|
The block will be performed under general anesthesia immediately before extubation, with the patient in the supine position under ultrasound guidance (Vivid Q).
After aseptic preparation, a high-frequency linear probe (11-12 MHz) covered with a sterile sheath and an 80-mm block needle (Braun 360°) will be used.
The probe will be positioned to identify the xiphoid process, rectus abdominis muscle, and sixth costal cartilage.
Using an in-plane technique, the needle will be advanced in a caudal-to-cephalic direction.
After confirmation of correct needle placement with 5 mL saline, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be injected on each side (total volume 40 mL).
Other Names:
Thirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®).
Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.
|
|
Active Comparator: Transversus abdominis plane block
TAP block will be performed, and standard postoperative pain management protocols will be applied.
|
Thirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®).
Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.
The transversus abdominis plane block will be performed immediately after completion of surgery and before extubation, with the patient in the supine position under ultrasound guidance( Vivid Q).
Following aseptic preparation, a high-frequency linear probe (11-12 MHz) and an 80-mm block needle (Braun 360°) will be used to identify the abdominal wall muscle layers at the anterior axillary line between the 12th rib and the iliac crest.
Using an in-plane technique, the needle will be advanced into the plane between the internal oblique and transversus abdominis muscles.
After confirmation of correct needle placement with 5 ml saline injection, 20 mL of 0.25% bupivacaine (Buvacaine, Polifarma ®) will be administered to each side (total volume 40 mL).
Other Names:
|
|
Active Comparator: Control group
Standard postoperative pain management protocols will be applied.
No plane block will be applied.
|
Thirty minutes before the end of surgery, all patients will receive the standard postoperative analgesia regimen consisting of intravenous ibuprofen 400 mg (Intrafen®) and intravenous tramadol 100 mg (Contramal®).
Postoperative patient assessment will be performed by an anesthesiologist who is not involved in the intervention.If the patient's NRS score is ≥4 at any time point, intravenous meperidine (Aldolan®) at a dose of 0.5 mg/kg will be administered as rescue analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: During the first 24 hours postoperatively
|
Total postoperative opioid consumption will be recorded for each patient during the first 24 hours after surgery.
Opioid use will be quantified based on the total dose of rescue opioid analgesics administered and compared between study groups to assess differences in postoperative opioid requirements.
|
During the first 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores
Time Frame: Postoperative hours 1, 3, 6, 12, 18, and 24.
|
Postoperative pain will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Pain scores will be recorded both at rest and during ambulation at 1, 3, 6, 12, 18, and 24 hours postoperatively.
NRS scores will be compared between study groups to evaluate differences in postoperative pain intensity.
|
Postoperative hours 1, 3, 6, 12, 18, and 24.
|
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Adverse events
Time Frame: During the first 24 hours postoperatively
|
Adverse events (nausea, vomiting, itching, ect) related to opioid use will be recorded for each patient
|
During the first 24 hours postoperatively
|
|
Postoperative Rescue Analgesic Consumption:
Time Frame: During the first 24 hours postoperatively
|
The use of rescue analgesics in the postoperative period will be recorded and compared between study groups to evaluate differences in the need for additional analgesia.
|
During the first 24 hours postoperatively
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.
- Dost B, Turunc E, Ozdemir E. Subxiphoid Pericardial Window Using a Combination of Rectointercostal Fascial Plane Block and Superficial Parasternal Intercostal Plane Block. J Cardiothorac Vasc Anesth. 2024 May;38(5):1282-1283. doi: 10.1053/j.jvca.2024.02.002. Epub 2024 Feb 4. No abstract available.
- Ciftci B, Omur B, Alver S, Akin AN, Yildiz Y, Tulgar S. The Medipol Combination: Novel Rectointercostal Fascial Plane Block and Pectointercostal Fascial Plane Block for Postoperative Analgesia Management After Cardiac Surgery: A Report of 15 Cases. A A Pract. 2024 Jun 5;18(6):e01794. doi: 10.1213/XAA.0000000000001794. eCollection 2024 Jun 1.
- Brogi E, Kazan R, Cyr S, Giunta F, Hemmerling TM. Transversus abdominal plane block for postoperative analgesia: a systematic review and meta-analysis of randomized-controlled trials. Can J Anaesth. 2016 Oct;63(10):1184-1196. doi: 10.1007/s12630-016-0679-x. Epub 2016 Jun 15.
- El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol Hospital 7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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