Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery

NCT05256953 | Completed

• 1 other identifier: CRCESP140619
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative pain scores

  Postoperative month 3

• The number of patient requiring rescue analgesia

  Postoperative day 1

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

  Postoperative day 1

• 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]

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

  Postoperative 7 days on an average

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

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

Procedure: Erector spina plane block + general anesthesia

Group GA

ACTIVE COMPARATOR

only IV morphine PCA

Procedure: Only general anesthesia

Interventions

Erector spina plane block + general anesthesia PROCEDURE

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

Group ESP

Only general anesthesia PROCEDURE

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

Group GA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Özgenur Kekül

Samsun, Other, 55200, Turkey (Türkiye)

Location

Related 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.

  PMID: 33403545 BACKGROUND

• 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.

  PMID: 30868029 BACKGROUND

• 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.

  PMID: 28919152 BACKGROUND

• 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.

  PMID: 32357842 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Yasemin Burcu Üstün, Prof

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: January 25, 2021
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)