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Bariatric Surgery CandidateNCT03798522

Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery

A study testing bilateral ultrasound guided erector spinae plane block and Nalbuphine in people with Bariatric Surgery Candidate and Morbid Obesity, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
bilateral ultrasound guided erector spinae plane block and Nalbuphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteEgypt
Study dates
1 Feb 2019to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Hany Mohammed El-Hadi Shoukat Mohammed

    Giza, 12211

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
bilateral ultrasound guided erector spinae plane block, Nalbuphine
Keywords
ultrasound guided regional blocks, laparoscopic surgery, erector spinae plane block
Medical subject headings
Obesity, Morbid, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bilateral ultrasound guided erector spinae plane blockProcedure or surgery

    Also called ESPB

    ESPB on both sides at T7 before GA

  • NalbuphineDrug

    Also called GA

    in nalbuphine for analgesia after GA

Study groups in NCT03798522
Study groupRoleWhat they receive
erector spinae plane block group (ESPB) n=14ExperimentalBilateral 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 .
Receives: Procedure: bilateral ultrasound guided erector spinae plane block
general anesthesia group (GA) n= 14Active comparatorthese patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA
Receives: Drug: Nalbuphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The duration of analgesic effect in minutes

    The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS

    Measured: 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

Secondary outcomes (10)

  1. mean arterial blood pressure changes

    mean arterial blood pressure will be assessed and measured in mmHg non invasively

    Measured: intraoperative and post extubation in the 1st hour

  2. Nalbuphine consumption

    in mg

    Measured: total dose given post operatively up to 1 hour postoperatively

  3. visual analogue scale (VAS) for assessment of postoperative pain

    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

    Measured: at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery

  4. Block failure rate

    patient required more than two 5mg doses of nalbuphine

    Measured: in the first hour postoperatively

  5. Resumption of peristalsis

    in hours

    Measured: postoperatively up to 48 hours postoperatively

  6. incidence of adverse effects

    postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation

    Measured: postoperative up to 48 hours

  7. Incidence of shoulder pain

    percent

    Measured: postoperativey up to 24 hours

  8. length of hospital stay

    in days

    Measured: postoperative up to 28 days postoperatively

  9. heart rate

    heart rate in beat per minute will be measured

    Measured: intraoperatively and throughout one hour postextubation

  10. Failure rate of the ESP block

    the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine

    Measured: in the first hour postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion30 Aug 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
* erector spinae plane block group (ESPB) * general anesthesia group (GA)
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03798522
Sponsor's protocol ID
N-42-2018
Status last verified
Jan 2020
First submitted
27 Dec 2018
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: yes

Questions about this trial

What is this clinical trial studying?

A study testing bilateral ultrasound guided erector spinae plane block and Nalbuphine in people with Bariatric Surgery Candidate and Morbid Obesity, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03798522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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