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Completed

NCT Number: NCT05225766

Comparison of Erector Spinae Plane Block and Rectus Sheath Block

In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.

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Key information

Conditions

Postoperative Pain, Acute Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University

Bursa, Nilüfer, 16059, Turkey (Türkiye)

About this study

Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-75 years
  • American Society of Anesthesiologists (ASA) classes I-III

Exclusion criteria

  • Local anesthetic allergy
  • Coagulopathy
  • Injection site infection
  • History of abdominal surgery
  • Severe neurological or psychiatric disorder
  • Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
  • chronic opioid use

Treatment and study plan

bupivacaine

Other

used for peripheral block

Primary outcomes

  1. intraoperative hemodynamic data and administered opioid doses

    Time frame: 150 minutes

    Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.

  2. postoperative visual analog scales at rest and during coughing

    Time frame: 48 hours

    Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.

  3. time to first patient controlled analgesia (PCA) dose

    Time frame: 48 hours

    The times when patients used the PCA device for the first time were recorded and compared between groups.

  4. postoperative morphine consumption

    Time frame: 48 hours

    Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.

  5. need for rescue analgesics

    Time frame: 48 hours

    Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.

  6. duration time until first mobilization

    Time frame: 48 hours

    The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.

  7. opioid side effects

    Time frame: 48 hours

    Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.

  8. patient and surgeon satisfaction

    Time frame: 48 hours

    Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Feb 7, 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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