Clinical trial NCT05256953: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Regional anesthesia
Erector spinae plane block
Post-operative analgesia
Laparoscopy
Open surgery
Colorectal surgery
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative morphine consumption in the first 24 hours
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: Postoperative month 3
measure: The number of patient requiring rescue analgesia
timeFrame: Postoperative day 1
measure: Number of patients with postoperative nausea-vomiting and need of antiemetic usage
timeFrame: Postoperative day 1
measure: Remifentanil consumption during the surgery
timeFrame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min]
measure: Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time
timeFrame: Postoperative 7 days on an average
measure: Incidence of pruitus
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Özgenur Kekül
state: Other
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: Yasemin Burcu Üstün, Prof
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.