Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

February 16, 2022 updated by: Yasemin Burcu Ustun, Ondokuz Mayıs University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Other
      • Samsun, Other, Turkey, 55200
        • Özgenur Kekül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group ESP
bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA
Procedure: Erector spina plane block + general anesthesia

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
ACTIVE_COMPARATOR: Group GA
only IV morphine PCA
Procedure: Only general anesthesia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative month 3
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
Postoperative day 1
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
Postoperative day 1
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.
The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min]
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
Postoperative 7 days on an average
Incidence of pruitus
Time Frame: Postoperative day 1
Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours
Postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Director: Yasemin Burcu Üstün, Prof, Ondokuz Mayıs University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2021

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (ACTUAL)

February 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCESP140619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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