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Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

O

Ondokuz Mayıs University

Status

Completed

Conditions

Pain, Postoperative

Treatments

Procedure: Only general anesthesia
Procedure: Erector spina plane block + general anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05256953
CRCESP140619

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Group ESP
Active Comparator group
Description:
bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA
Treatment:
Procedure: Erector spina plane block + general anesthesia
Group GA
Active Comparator group
Description:
only IV morphine PCA
Treatment:
Procedure: Only general anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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