- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384000
Comparison Between External Oblique Intercostal Plane Block and Rectus Sheath Block Combined With Transversus Abdominis Plane Block
The Efficacy of Single Puncture Technique of Rectus Sheath Block Combined With Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Pain Control After Laparoscopic Cholecystectomy.
Study Overview
Status
Conditions
Detailed Description
This study aims to investigate the analgesic efficacy of external oblique intercostal plane (EOIPB) versus single puncture technique of rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) after laparoscopic cholecystectomy.
Primary Outcome:
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
Secondary Outcomes:
the analgesic efficacy (Sensory assessment) by defined dermal zones in the first 24 hours postoperatively.
pain intensity at rest and during coughing using verbal rating scale in the first 24 hours postoperatively.
Patient satisfaction in the first 24 hours postoperatively. The hemodynamic changes. Time to first rescue analgesia. First off-bed activity Incidence of block-related complications. Signs of local anesthetic toxicity hypotension ,bradycardia ,tachyarrhythmia, postoperative nausea and vomiting (PONV) and dizziness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Osama Mohamed, Master degree
- Phone Number: +201033231080 +201013833227
- Email: Usamakhaled286@gmail.com
Study Contact Backup
- Name: Menna Tallah Mamdouh Lecturer, Lecturer
- Phone Number: +201005306945
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) 1-II
- aged 18-70 years
- both genders will be included.
- body mass index (BMI) ≤ 35 kg/m2.
Exclusion Criteria:
- coagulation disorders
- liver/kidney disease
- History of abdominal surgery
- infection in the block application area
- chronic opioid use
- local anesthetic (LA) allergy
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: external intercostal plane block intervention with ultra sound
Patients in this group will receive (EOIPB) bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side.
|
Patients in this group will receive external intercostal plane block bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side.
|
|
Active Comparator: single-puncture technique of (RSB) combined with (TAPB) by ultra sound
Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .
|
Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .
|
|
Placebo Comparator: control group (nalbuphine)
Patients in this group will not receive any intervention or nerve block.
|
Patients in this group will not receive any intervention or nerve block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrase the consumption of opioids
Time Frame: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
|
The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.
|
Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The analgesic efficacy (sensory assessment)
Time Frame: First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively
|
Sensory assessment by defined dermal zones at 1, 2, 6, 12, and 24 hours postoperatively. The specific dermal zones will be described by vertical lines at the midline (A), mid-clavicular line (B), anterior axillary line (C), mid-axillary line (D), posterior axillary line (E), infrascapular line (F), and back midline (J). Four horizontal lines at the xiphoid level (a),12th costal level (b), the umbilical level (c), the anterior superior iliac spine to the pubic symphysis line (d), and extension to the back to the anterior superior iliac spine level (e). An additional zone will be defined as the upper 1/3 of the front thigh . Sensory assessment will be achieved using 70% ethyl alcohol swab and pinprick at 1,2, 6, 12, and 24 hours postoperatively after extubation at specific dermal zones divided by anatomic landmark lines on the abdomen, the back, and the thigh. Effective analgesic efficacy was defined as loss of cold temperature sensation to alcohol swab or loss of pinprick pain sensat |
First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively
|
|
Pain intensity
Time Frame: Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
|
pain intensity will be assessed at rest and during coughing using verbal rating scale (Jensen & Karoly 1992) every hour till 6 hour, then every 2 hours till 12 hours, then every 4 hours till 24 hours. postoperatively as: No pain (=1) , Mild pain(=2) , Moderate pain(=3) , Sever pain(=4). |
Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative
|
|
Off bed activity
Time Frame: 24 hours postoperative
|
time of the first off-bed activity after surgery in minutes , comparison between all arms and intervention
|
24 hours postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;24(1):58. doi: 10.1186/s12871-024-02444-6. PMID: 38336613; PMCID: PMC10854179.
Helpful Links
- White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. PMID: 35249704.
- Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;2
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
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Agnosia
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Heterocyclic Compounds, 4 or More Rings
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Nalbuphine
- Control Groups
Other Study ID Numbers
- nerve block in pain management
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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