ClinicalTrials.gg
Status unknownNCT04313764Updated Jun 4, 2020

Ultrasound-Guided Erector Spinae Plan Block for Colorectal Surgery

An interventional study of Bupivacaine Hcl 0.25% ESP block and Bupivacaine Hcl 0.25% infiltration in Colorectal Cancer and Postoperative Pain, sponsored by Ataturk University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Postoperative Pain
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 48 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Ataturk University is the lead sponsor of 454 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • renal or hepatic insufficiency, chronic pain, patients with an allergic reaction to anesthesia and analgesia drugs to be used
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Group ESPB

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

    Drug: Bupivacaine Hcl 0.25% ESP block

  • Active comparator
    Group Infiltration

    Wound infiltration with 20 ml %0.25 bupivacaine

    Drug: Bupivacaine Hcl 0.25% infiltration

Interventions

06

What researchers measure

Primary outcomes

  1. Opioid Consumption

    Opioid consumption postroperative period

    Time frame: Postoperative first 24 hours

Secondary outcomes

  1. Visual Analog Pain Score

    Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

    Time frame: Postoperative first 24 hours

07

Study locations

1 site
  • Ataturk University
    Erzurum, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 29381824 ↗
  • 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. PubMed 31695476 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2020; primary completion for Jul 2020, 1 month later.

Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 1 month is below that.

Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2020
First posted
Mar 18, 2020
StartEst.
Jun 18, 2020
Primary completionEst.
Jul 30, 2020
CompletionEst.
Aug 15, 2020
Last update
Jun 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04313764
Lead sponsor
Ataturk University
Responsible party
Ahmet Murat Yayik (Medical Doctor, Ataturk University) — Principal investigator
First posted
Mar 18, 2020
Start date
Jun 18, 2020 (estimated)
Primary completion
Jul 30, 2020 (estimated)
Completion
Aug 15, 2020 (estimated)
Last update
Jun 4, 2020

Study contacts

İrem Ates, MD
Contact
driremates@hotmail.com
00905327401258
Ali Ahiskalioglu, MD
Contact
aliahiskalioglu@hotmail.com
00905444424831

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Bupivacaine

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