NCT04313764

Brief Summary

Colorectal cancer is a common and lethal disease. It still remains the third most common cause of cancer death in women and the second leading cause of death in men. Pain control is an important direction of postoperative management in malignancy surgery. Inadequate pain control increases cardiac and respiratory complications in these critical patients. Erector spinae plane (ESP) block is a recently described regional anesthesia technique that blocks the dorsal and ventral rami of the spinal nerves and the sympathetic nerve fibers. While the ESP block has been shown to provide effective postoperative analgesia after thoracic, and abdominal surgeries. Our aim in this study was to investigate bilateral thoracic ESP block for providing successful postoperative pain management following colorectal surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

March 17, 2020

Last Update Submit

June 3, 2020

Conditions

Colorectal CancerPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    Opioid consumption postroperative period

    Postoperative first 24 hours

Secondary Outcomes (1)

  • Visual Analog Pain Score

    Postoperative first 24 hours

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Drug: Bupivacaine Hcl 0.25% ESP block

Group Infiltration

ACTIVE COMPARATOR

Wound infiltration with 20 ml %0.25 bupivacaine

Drug: Bupivacaine Hcl 0.25% infiltration

Interventions

Bupivacaine Hcl 0.25% ESP blockDRUG

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side

Group ESPB
Bupivacaine Hcl 0.25% infiltrationDRUG

Wound infiltration with 20 ml %0.25 bupivacaine

Group Infiltration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-II-III patients undergoing Colorectal surgery

You may not qualify if:

  • renal or hepatic insufficiency, chronic pain, patients with an allergic reaction to anesthesia and analgesia drugs to be used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.

    PMID: 29381824BACKGROUND

  • Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019.

    PMID: 31695476BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

İrem Ates, MD

CONTACT

00905327401258driremates@hotmail.com

Ali Ahiskalioglu, MD

CONTACT

00905444424831aliahiskalioglu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 18, 2020

Study Start

June 18, 2020

Primary Completion

July 30, 2020

Study Completion

August 15, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

TU(1)