An interventional study of Erector spina plane block + general anesthesia and Only general anesthesia in Pain, Postoperative, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA
Procedure: Erector spina plane block + general anesthesia
only IV morphine PCA
Procedure: Only 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).
Also known as: Group ESP
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).
Also known as: Group GA
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).
Time frame: Postoperative day 1
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.
Time frame: 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
Time frame: 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
Time frame: Postoperative day 1
Remifentanil consumption during the surgery
The total amount of remifentanil consumed will be recorded.
Time frame: 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
Time frame: 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
Time frame: Postoperative day 1
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Ondokuz Mayıs University