Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Sponsor

Ondokuz Mayıs University (Other)

Overall Status

Completed

CT.gov ID

NCT05256953

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: Erector spina plane block + general anesthesia Procedure: Only general anesthesia	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The patients were randomly divided into two groups of 30 patients each. In the system where computer generated random numbers (SPSS v23.0, IBM, NewYork, USA) were used, ESP and GA groups were determined at a ratio of 1:1. Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the block procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group. The care provider and investigator were also blinded to the participant.

Primary Purpose:

Treatment

Official Title:

Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Actual Study Start Date :

Jan 25, 2021

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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
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.
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
Incidence of pruitus [Postoperative day 1]
Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.