Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Only general anesthesia; Procedure: Erector spina plane block + general anesthesia

• Registration Number: NCT05256953
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

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 Timeline

• Study Start: 2021-01-25
• Primary Completion: 2021-03-01
• Study Completion: 2021-05-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative morphine consumption in the first 24 hours	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 Outcome Measures

Name	Time	Method
Postoperative pain scores	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.
Remifentanil consumption during the surgery	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.
Incidence of pruitus	Postoperative day 1	Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours
The number of patient requiring rescue analgesia	Postoperative day 1	The number of patients who required rescue analgesics were recorded at 0, 1, 3, 6, 12 and 24. hours after extubation
Number of patients with postoperative nausea-vomiting and need of antiemetic usage	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 first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time	Postoperative 7 days on an average	Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time were recorded

Trial Locations

Locations (1)

Özgenur Kekül; 🇹🇷 Samsun, Other, Turkey