- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798522
Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery
Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study
bilateral continuous erector spinae plane blockade may represent a valuable alternatives to thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain.
There were 3 cases reported in 2017 suggested that the erector spinae plane block provides visceral abdominal analgesia in bariatric surgery and at end of the report they recommended further clinical investigation. The investigators hypothesіzed that performing the erector spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic effect of erector spinae plane block and opioid based general anesthesia for laparoscopic bariatric surgeries.
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators hypothesized that, erector spinae plane block will provide good analgesia for patients undergoing laparoscopic bariatric surgery with less complication compared to opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to all participants before conduction of anesthesia. All the drugs will be calculated according to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae plane block will be performed under complete aseptic conditions in the lateral position at T7 vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector spinae plane. This procedure will be repeated on the contralateral side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body weight after induction of general anesthesia. All participants will be given 1 gram of intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after intubation by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation will be managed by intravenous administration of fentanyl 0.5 µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded 4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by intravenous infusion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt, 12211
- Hany Mohammed El-Hadi Shoukat Mohammed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient age >18 <60
- Obese patients 40˂ Body mass index(BMI) ˂50
- Both sexes
- American Society of Anesthesiologists(ASA) physical status classes II and III
- Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB)surgeries
Exclusion Criteria:
- Refusal of regional block
- Patients with neurological, psychological disorders or those lacking cooperation
- Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
- Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- Patients with bleeding disorders defined as (INR >2) and/ or (platelet count <100,000/µL)
- Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- Patients who are allergic to amide local anesthetics.
- Cases converted to open surgery will also be excluded from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: erector spinae plane block group (ESPB) n=14
Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP.
This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted .
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ESPB on both sides at T7 before GA
Other Names:
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Active Comparator: general anesthesia group (GA) n= 14
these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA
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in nalbuphine for analgesia after GA
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The duration of analgesic effect in minutes
Time Frame: defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively
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The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS
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defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean arterial blood pressure changes
Time Frame: intraoperative and post extubation in the 1st hour
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mean arterial blood pressure will be assessed and measured in mmHg non invasively
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intraoperative and post extubation in the 1st hour
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Nalbuphine consumption
Time Frame: total dose given post operatively up to 1 hour postoperatively
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in mg
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total dose given post operatively up to 1 hour postoperatively
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visual analogue scale (VAS) for assessment of postoperative pain
Time Frame: at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
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in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable.
if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia
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at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery
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Block failure rate
Time Frame: in the first hour postoperatively
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patient required more than two 5mg doses of nalbuphine
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in the first hour postoperatively
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Resumption of peristalsis
Time Frame: postoperatively up to 48 hours postoperatively
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in hours
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postoperatively up to 48 hours postoperatively
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incidence of adverse effects
Time Frame: postoperative up to 48 hours
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postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation
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postoperative up to 48 hours
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Incidence of shoulder pain
Time Frame: postoperativey up to 24 hours
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percent
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postoperativey up to 24 hours
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length of hospital stay
Time Frame: postoperative up to 28 days postoperatively
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in days
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postoperative up to 28 days postoperatively
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heart rate
Time Frame: intraoperatively and throughout one hour postextubation
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heart rate in beat per minute will be measured
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intraoperatively and throughout one hour postextubation
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Failure rate of the ESP block
Time Frame: in the first hour postoperatively
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the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine
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in the first hour postoperatively
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
demographic data
Time Frame: during 30 minutes preoperatively
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age, sex, ASA class, co-morbidities
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during 30 minutes preoperatively
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duration of surgery
Time Frame: from skin incision up to skin closure
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in minutes
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from skin incision up to skin closure
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weight
Time Frame: during 30 minutes preoperatively
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kilograms
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during 30 minutes preoperatively
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height
Time Frame: during 30 minutes preoperatively
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meter
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during 30 minutes preoperatively
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body mass index (BMI)
Time Frame: uring 30 minutes preoperatively
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weight in kilograms divided by square height in meter
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uring 30 minutes preoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Pain
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Nociceptive Pain
- Obesity, Morbid
- Visceral Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Nalbuphine
Other Study ID Numbers
- N-42-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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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