NCT06370949

Brief Summary

Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients. Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries.

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
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

April 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 13, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

colorectal cancercolorectal cancer surgerycolorectal neoplasymtransversus abdominis planetransversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery

    Numeric Rating Scales of two groups in postoperative period. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    postoperative day two

Study Arms (2)

bupivacaine

Ultrasonography (USG) guided bilateral TAP block:20 ml %0,25 concentration bupivacain

Drug: Bupivacain

bupivacaine+dexmedetomidine

Ultrasonography (USG) guided bilateral TAP block: 20 ml %0,25 concentration bupivacain+ 0.5 mcg/kg dexmedetomidine

Drug: bupivacain+dexmedetomidine

Interventions

Ultrasonography (USG) guided bilateralTAP block:20 ml %0,25 concentration bupivacain

bupivacaine

Ultrasonography (USG) guided bilateral TAP block: 20 ml %0,25 concentration bupivacain+ 0.5 mcg/kg dexmedetomidine

bupivacaine+dexmedetomidine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators will evaluate colorectal cancer patients from Ankara Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospital who will undergo colorectal cancer surgery. The investigators will exclude patients who no longer want to participate at any part of the trial. A total of 84 patients' data will be collected.

You may qualify if:

  • colorectal cancer diagnosis
  • undergoing colorectal cancer surgery

You may not qualify if:

  • allergic reaction to local anesthetics
  • bleeding anomalies
  • infection in TAP block area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Ankara, Cankaya, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Beyza Seker, MD

    Resident MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beyza Seker, MD

CONTACT

Hazal E Guran Aytug, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Anaesthesiologist

Study Record Dates

First Submitted

April 13, 2024

First Posted

April 17, 2024

Study Start

May 1, 2024

Primary Completion

September 30, 2024

Study Completion

November 30, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations