Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Study Overview
=================
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.

Official Title
-----------------
Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Erector spina plane block + general anesthesia
* Procedure: Only general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESP<br>bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA | Procedure: Erector spina plane block + general anesthesia<br>* 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).<br>* Other names: Group ESP;|
| Active Comparator: Group GA<br>only IV morphine PCA | Procedure: Only general anesthesia<br>* 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).<br>* 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 | 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 | 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 | 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 | 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 | 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 | 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 | Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours | Postoperative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery