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Completed

NCT Number: NCT05256953

Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özgenur Kekül

Samsun, Other, 55200, Turkey (Türkiye)

About this study

Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period.

In this study, the hypothesis was determined as "Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores."

The patients were divided into two groups :

Group ESP (erector spinae plan):

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group GA (general anesthesia):

In this group, patients will be administered only IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 18 and 65 years
  • ASA I , II patients
  • BMI<35 kg/m2 (body weight <100 kg , >45 kg)
  • Patients who underwent colorectal surgery

Exclusion criteria

  • Patients who underwent abdominoperineal resection
  • Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied.
  • Patients diagnosed with OSAS
  • Pregnancy and breastfeeding
  • Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
  • Hypersensitivity to local anesthetics or a history of allergy
  • Patients with a history of opioid use longer than four weeks
  • Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient.
  • Patients with anatomic deformity ( advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity )
  • Patients who do not want to participate
  • Patients who have had previous colorectal surgery, excluding diagnostic biopsies
  • Patients who could not be reached by phone to inquire about their pain score at 3rd month.

Treatment and study plan

Erector spina plane block + general anesthesia

Procedure

Bilateral-injection ultrasound-guided bilateral erector spinae plane block

Pre-operatively, with the patient in the sitting position, 20ml 0.25% bupivacaine will be administered between the T9 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. The same procedure was applied bilaterally.

Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.

Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).

Other names: Group ESP

Only general anesthesia

Procedure

Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied.

Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score >3, (max doses 300 mg/day).

Other names: Group GA

Primary outcomes

  1. Postoperative morphine consumption in the first 24 hours

    Time frame: Postoperative day 1

    Morphine consumption in the first 24 hours were measured. Patients will be able to request opioids via a PCA device when their VAS score is above 3 at rest and during activity (coughing and deep breathing).

Secondary outcomes

  1. Postoperative pain scores

    Time frame: Postoperative month 3

    Pain status at rest and while activity (coughing and deep breathing) were assessed by VAS scores at 0, 1, 3, 6, 12, 24 hours and 3th month after extubation. The VAS is an 11 point numeric scale which ranges from 0 to 10 at rest and during activity.

  2. The number of patient requiring rescue analgesia

    Time frame: Postoperative day 1

    The number of patients who required rescue analgesics were recorded at 0, 1, 3, 6, 12 and 24. hours after extubation

  3. Number of patients with postoperative nausea-vomiting and need of antiemetic usage

    Time frame: Postoperative day 1

    The severity of postoperative nausea and vomitting (PONV) was assessed using a descriptive verbal rating scale at 0, 1, 3, 6, 12 and 24 hours after extubation. If a score of 2 or more granisetron 1,5 mg iv will be administered. The PONV scale 0= no nausea, 1= slight nausea 2= moderate nausea, 3= vomiting once, 4= vomiting more than once

  4. Remifentanil consumption during the surgery

    Time frame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min]

    The total amount of remifentanil consumed will be recorded.

  5. Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time

    Time frame: Postoperative 7 days on an average

    Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time were recorded

  6. Incidence of pruitus

    Time frame: Postoperative day 1

    Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2022
Registry last updated
Feb 25, 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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