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Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Erector spina plane block + general anesthesia

Only general anesthesia

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Özgenur Kekül

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group ESP

Group GA

Arm Description

bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA

only IV morphine PCA

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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

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

Remifentanil consumption during the surgery

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 first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time were recorded

Incidence of pruitus

Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours

Full Information

NCT ID

NCT05256953

First Posted

February 16, 2022

Last Updated

February 16, 2022

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT05256953

Brief Title

Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Official Title

Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 25, 2021 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Care ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group ESP

Arm Type

Active Comparator

Arm Description

bilateral ESPB (total of 40 ml, %0.25 bupivacaine) + IV morphine PCA

Arm Title

Group GA

Arm Type

Active Comparator

Arm Description

only IV morphine PCA

Intervention Type

Procedure

Intervention Name(s)

Erector spina plane block + general anesthesia

Other Intervention Name(s)

Group ESP

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Only general anesthesia

Other Intervention Name(s)

Group GA

Intervention Description

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).

Primary Outcome Measure Information:

Title

Postoperative morphine consumption in the first 24 hours

Description

Time Frame

Postoperative day 1

Secondary Outcome Measure Information:

Title

Postoperative pain scores

Description

Time Frame

Postoperative month 3

Title

The number of patient requiring rescue analgesia

Description

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

Title

Number of patients with postoperative nausea-vomiting and need of antiemetic usage

Description

Time Frame

Postoperative day 1

Title

Remifentanil consumption during the surgery

Description

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]

Title

Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time

Description

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

Title

Incidence of pruitus

Description

Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours

Time Frame

Postoperative day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasemin Burcu Üstün, Prof

Organizational Affiliation

Ondokuz Mayıs University Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Özgenur Kekül

City

Samsun

State/Province

Other

ZIP/Postal Code

55200

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33403545

Citation

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.

Results Reference

background

PubMed Identifier

30868029

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.

Results Reference

background

PubMed Identifier

28919152

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.

Results Reference

background

PubMed Identifier

32357842

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.

Results Reference

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Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

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