- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654556
Investigating the Analgesic Efficacy and Ease of Perfomance of Modified Throracoabdominal Plane Block and Comparing it With Erector Spinea Plane Block in Laparacopic Sleeve Gasterctomy Surgeries
Evaluating Analgesic Efficacy and Feasibility of Modified Thoracoabdominal Plane Block Compared With Erector Spinae Plane Block in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study
Interest in surgical weight loss interventions continues to rise in the face of what has been dubbed the obesity epidemic. The most popular of these weight loss interventions is laparoscopic sleeve gastrectomy, which has proven to reduce morbidity and mortality of morbidly obese patients. The aim of effective perioperative pain management extends beyond increased patient comfort and includes reduced recumbency period, enhanced recovery, reduced hospital stay, and lowers postoperative complication rates.
Effective postoperative pain management has traditionally relied on multimodal strategies that combine systemic opioids, non-opioid medications, and regional anesthesia. Despite their efficacy, opioids are associated with a range of undesirable effects, such as nausea, vomiting, sedation, pruritus, and respiratory depression, which may impede early mobilization and recovery. These concerns have accelerated the adoption of ultrasound-guided regional anesthesia techniques as part of Enhanced Recovery After Surgery (ERAS) protocols, delivering superior pain control with fewer systemic adverse effects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Among the newer regional techniques described for thoracoabdominal analgesia are the Modified thoracoabdominal plane block through perichondrial approach (M-TAPA) block and the erector spinae plane (ESP) block. The visceral analgesic effect of ESPB appears inconsistent and may be limited by technical and anatomical factors. ESPB requires relatively deep needle placement at thoracic levels, and achieving reliable anterior spread of local anesthetic is highly operator dependent. These challenges may be exacerbated in obese patients undergoing bariatric surgery, in whom ultrasound visualization and needle control can be technically demanding. Furthermore, uncertainty regarding the mechanism and extent of visceral afferent blockade, along with concerns about potential complications related to deep paraspinal injection, may limit the reproducibility and routine clinical applicability of ESPB in this population.
In contrast, the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a more superficial and anatomically predictable technique designed to block thoracoabdominal nerves supplying the upper abdominal wall. Emerging evidence suggests that M-TAPA provides effective postoperative analgesia and opioid-sparing benefits in upper abdominal laparoscopic surgery, with a simpler and potentially safer technical profile compared with deeper regional techniques. Given its reduced operator dependency and technical simplicity, M-TAPA may represent an appealing alternative for patients undergoing laparoscopic sleeve gastrectomy. However, direct comparative evidence between ESPB and M-TAPA in this specific surgical context, particularly with respect to visceral pain control, remains lacking. Therefore, a randomized comparison of these two techniques is warranted.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hesham khedr Prof. Dr., Professor
- Phone Number: 02 01001622640
- Email: hkhishamkhedr@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients from both sexes.
- 18 to 60 years old.
- ASA physical status II-III scheduled for laparoscopic sleeve gastrectomy.
- Patients with BMI (40-50) kg/ m2
Exclusion Criteria:
- Patient Refusal
- Lack of patient cooperation.
- Patients with any contraindication to regional nerve blocks as coagulopathy or infection at site of injection
- Patients with anatomical abnormalities at site of injection
- Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
- Patients with pre-existing neurological disorder
- Patients with chronic pain syndromes including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
- Patients with history of long-acting opioids, steroids, anticonvulsants perioperatively.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Modified thoracoabdominal plane block through perichondrial approach (M-TAPA)
The M-TAPA block will be performed after induction of general anaethesia, with total volume of 25ml of 0.25% bupivacaine.
|
A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided M-TAPA block.
|
|
Active Comparator: Erector Spinea plane block (ESP block)
The ESP block will be performed after induction of general anaethesia , with total volume of 40 ml of 0.25% bupivacaine.
|
A bilateral injection of 25 ml of 0.25% bupivacaine will be injected as a part of ultrasound guided ESP block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Visual Analogue Score
Time Frame: 48 hours
|
Measurment of postoperative Visual Analogue Score after 48 hours
|
48 hours
|
|
Postoperative Visual Analogue Score
Time Frame: 48 hours
|
Postoperative Visual Analogue Score
|
48 hours
|
Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-79-2026
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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