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NCT Number: NCT05020379

The Effects of Erector Spinae Plane Block on Bariatric Surgery.

The erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Poorly controlled early postoperative pain impairs quality of recovery, increases the risk of postoperative pulmonary complications, and is a risk factor for the subsequent development of chronic pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing bariatric surgery. The primary aim of this prospective, randomized study is to evaluate the effect of ESPB on quality of recovery with the QoR-40 questionnaire in patients undergoing elective Laparoscopic Bariatric Surgery.

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Key information

Conditions

Laparoscopic Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

In the operating room, all patients will receive standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation. Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. The needle tip was advanced until it will be located in the inter-fascial plane deep to the erector spinae muscle group and superior to the transverse process. Once in position, bupivacaine 0.25%, 20 ml was injected under ultrasound, guidance. The same procedure will be repeated on the contralateral site. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be recorded on the 15th,30th minute, 1st, 2nd, 12th, 24th hour, 2nd day. Quality of recovery-40 (QoR-40) scores will be given on the ward, at postoperative 24th hour, 3rd and 7th day ( the 3rd and 7th-day scores will be calculated after telephone interview if the patient will be discharged from the hospital).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Scheduled for elective laparoscopic bariatric surgery

Exclusion criteria

  • a history of allergy to local anesthetics
  • known coagulation disorders
  • infection near the puncture site
  • Chronic opioid intake
  • Patient with psychiatric disorders
  • Can not communicate in Turkish

Treatment and study plan

Perioperative and postoperative multimodal analgesia

Procedure

Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.

The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.

Other names: Global Quality of Recovery-40 score, Standard Pain Follow up

ESP block

Procedure

Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep face of the erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.

Other names: Global Quality of Recovery-40 score, Standard Pain Follow up

Primary outcomes

  1. Quality of Recovery (QoR-40) score

    Time frame: postoperative 24th hour

    QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.

Secondary outcomes

  1. Postoperative pain: numeric rating scale (NRS)

    Time frame: Postoperative 48 hour

    NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system

  2. Analgesic consumption

    Time frame: Postoperative 48 hour

    Total opioid consumption at the postoperative period

  3. Side effects

    Time frame: 24 hours

    Rate of side-effect occurrences (such as rate of vomiting,nausea,dizziness)

  4. Sedation score

    Time frame: Postoperative 48 hour

    Evaluation of the level of sedation in patients with a 4-point scale (0=wake, 1=sleepy, easy to verbally arouse, 2=drowsy, 3=does not open their eyes to verbal commands).

  5. mobilization time

    Time frame: Postoperative 24 hour

    The time after surgery to the mobilization of the patient

  6. Quality of Recovery (QoR-40) score

    Time frame: Postoperative 3rd and 7th days

    QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200. The increase in scores show high quality of recovery.

  7. Postoperative complications

    Time frame: Postoperative 30 days

    Postoperative complications will be identified by visiting patients every day or alternate day during their in hospital course, suplemented by patients medical records using our hospital's electronic patient record database. We will use the Claviene Dindo Classification system from which CC is derived. We defined a postoperative complication as any deviation from the ideal postoperative course, not inherent in the procedure itself and does not constitute a failure to cure. CCI scores willbe calculated using the online CCI calculator.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Investigation of The Effects of The Erector Spinae Plane Block on The Quality Of Recovery After Laparoscopic Bariatric Surgery: A Prospective Randomized Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Oct 28, 2022

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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