- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311525
Ultrasound-Guided RSCTL vs EOIP Block for Analgesia in Sleeve Gastrectomy
Efficacy of Ultrasound-guided Retro Superior Costotransverse Ligament Space Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Study
Study Overview
Status
Conditions
Detailed Description
Obesity is ranked as the 5th cause of preventable death and is associated with certain diseases, e.g., type 2 diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO). Bariatric surgery is the most effective treatment for weight loss, reducing obesity-related comorbidities and mortality. This surgery has been shown to improve quality of life. Bariatric surgery is now universally performed laparoscopically and is the most performed elective surgery in patients with morbid obesity. Laparoscopic sleeve gastrectomy (LSG) has been shown to be related to lower complication rates, shorter hospital stays, and earlier re-engagement in normal activities than open procedures. However, postoperative pain is common. Pain often originates from port sites in the abdominal wall. As LSG requires removal of the relatively large resected gastric segment, this often requires enlargement of the trocar site and the fascial incision, which adds to the pain. Postoperative pain may be significant and has a negative impact on recovery, respiration, hemodynamics, mentation, ambulation, bowel function, and length of hospital stay. Also, opioid analgesia in obese patients is associated with serious adverse effects such as hypopnoea, hypoxaemia, drowsiness, ileus, vomiting, delayed ambulation, and mortality. These complications are compounded by pre-existing obstructive sleep apnea (OSA), cardiorespiratory insufficiency, psychiatric disorders, and chronic opioid use, which may be present in obese patients. Although epidural anesthesia is effective in pain control, positioning is extremely difficult in obese patients. Some regional anesthesia techniques such as transverse abdominis plane (TAP) block, quadratus lumborum (QL) block, and erector spinae plane (ESP) block may be used as a part of a multimodal analgesic regimen to reduce opioid consumption
. However, technical challenges such as difficulty in identifying the structures and limitations in needle movement may be experienced due to the deep anatomical location of structures when performing these blocks in patients with obesity.
Intertransverse process block (ITPB) is a paraspinal thoracic nerve block technique where the local anesthetic (LA) is injected into the thoracic "intertransverse tissue complex", behind the superior costotransverse ligament (SCTL). The retro superior costotransverse ligament space (retro-SCTL space) block is a novel ITPB, targeting the fat-filled space in the retro-SCTL space. ITPB may be technically simpler and safer to avoid pleural puncture than a thoracic paravertebral block (TPVB) since it does not require direct needle access to the thoracic paravertebral space.
External oblique intercostal plane (EOI) block, a nerve block , has an efficacy range of T6-10. EOI block is one of the novel interfascial plane blocks. EOI block can be performed as part of multimodal analgesia for upper abdominal surgeries. In addition, easy visualization of the application area with ultrasound guidance is an advantage for obese patients. While both retro-SCTL and EOI blocks are emerging techniques, a direct comparison of their analgesic efficacy and opioid-sparing effects in the context of LSG has not yet been performed. This study aims to directly address this gap.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina M Fakhry, MD
- Phone Number: 00201289998680
- Email: dina_fakhry_91@yahoo.com
Study Locations
-
-
Beni Suweif Governorate
-
Banī Suwayf, Beni Suweif Governorate, Egypt, 62511
- Recruiting
- Beni-suef university Hospital
-
Contact:
- Dina M Fakhry, MD
- Phone Number: 01289998680
- Email: drdina.mahmoud@med.bsu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 to 65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-II
- Body mass index (BMI) > 40 kg m-2,
Exclusion Criteria:
- Obesity secondary to an endocrine disorder
- known allergic diathesis to any drugs used in the study
- Presence of serious systemic illness (e.g., severe cardiac, pulmonary, renal, or hepatic dysfunction),
- Coagulation dysfunction
- Pre-existing psychological disorders
- Current use of analgesic or psychotropic medications
- Infection at a potential injection site
- Ahistory of chronic pain
- Conversion to laparotomy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: retro-SCTL block
Participants in the (group retro-SCTL) will receive ultrasound-guided retro-SCTL space block after intubation.
Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected.
The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
|
Participants will receive ultrasound-guided Retro superior costotransverse ligament space block after intubation.
Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected.
The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
|
|
Active Comparator: EOI block
Participants in the (group EOI) will receive ultrasound-guided EOI block after intubation.
Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected.
The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
|
Participants will receive ultrasound-guided External Oblique Intercostal Plane Block after intubation.Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected.
The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cumulative morphine consumption within the first 24 hours.
Time Frame: 24 hours post operative
|
cumulative morphine consumption within the first 24 hours.
|
24 hours post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale (VAS) score for pain
Time Frame: 30 minutes, 1, 3, 6, 12, 24 hours postoperatively
|
The VAS is a pain rating scale.
Scores are based onself-reported measures of symptoms that are recorded witha single handwritten mark placed at one point along thelength of a 10-cm line that represents a continuum betweenthe two ends of the scale-"no pain" on the left end (0 cm) ofthe scale and the "worst pain" on the right end of the scale(10 cm).Visual analogue scale (VAS) score: will be assessed at rest and during movement at 30 min, 1, 3, 6, 12, 24 h postoperatively.
A score ≤ 3 will be considered acceptable for pain relief.
Supplementary rescue analgesia will be administered in the form of morphine IV 2 mg (at VAS ≥ 4), which may be repeated after 20 minutes.
|
30 minutes, 1, 3, 6, 12, 24 hours postoperatively
|
|
A Sedation scale
Time Frame: Initial 24 hours postoperatively
|
A Sedation scale will be applied to determine the sedation scores (0 = awake, 1 = drowsy, 2 = asleep but arousable, and 3 = deeply asleep).
A sedation score of > 0 indicates being sedated at any time throughout the initial postoperative 24 hours
|
Initial 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dina M Fakhry, MD, Beni-Suef University
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
- FMBSUREC/05102025/Fakhry
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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