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NCT Number: NCT03798522

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hany Mohammed El-Hadi Shoukat Mohammed

Giza, 12211, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral ultrasound guided erector spinae plane block

Procedure

ESPB on both sides at T7 before GA

Other names: ESPB

Nalbuphine

Drug

in nalbuphine for analgesia after GA

Other names: GA

Primary outcomes

  1. 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

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

Secondary outcomes

  1. mean arterial blood pressure changes

    Time frame: intraoperative and post extubation in the 1st hour

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

  2. Nalbuphine consumption

    Time frame: total dose given post operatively up to 1 hour postoperatively

    in mg

  3. 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

    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

  4. Block failure rate

    Time frame: in the first hour postoperatively

    patient required more than two 5mg doses of nalbuphine

  5. Resumption of peristalsis

    Time frame: postoperatively up to 48 hours postoperatively

    in hours

  6. incidence of adverse effects

    Time frame: postoperative up to 48 hours

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

  7. Incidence of shoulder pain

    Time frame: postoperativey up to 24 hours

    percent

  8. length of hospital stay

    Time frame: postoperative up to 28 days postoperatively

    in days

  9. heart rate

    Time frame: intraoperatively and throughout one hour postextubation

    heart rate in beat per minute will be measured

  10. Failure rate of the ESP block

    Time frame: in the first hour postoperatively

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

Other outcomes

  1. demographic data

    Time frame: during 30 minutes preoperatively

    age, sex, ASA class, co-morbidities

  2. duration of surgery

    Time frame: from skin incision up to skin closure

    in minutes

  3. weight

    Time frame: during 30 minutes preoperatively

    kilograms

  4. height

    Time frame: during 30 minutes preoperatively

    meter

  5. body mass index (BMI)

    Time frame: uring 30 minutes preoperatively

    weight in kilograms divided by square height in meter

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Analgesic Efficacy of Erector Spinae Plane Block Versus Opioid Based General Anesthesia During Laparoscopic Bariatric Surgery; a Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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