Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Pain, Postoperative Clinical Trial

Official title:

Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256953
• Other study ID #: CRCESP140619
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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).
• 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).

Locations

Country	Name	City	State
Turkey	Özgenur Kekül	Samsun	Other

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6. Review. — View Citation

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12. — View Citation

Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8. — View Citation

Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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]
Secondary	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
Secondary	Incidence of pruitus	Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours	Postoperative day 1