NCT04143542

Brief Summary

This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

8 days

First QC Date

October 23, 2019

Last Update Submit

April 21, 2020

Conditions

Keywords

quadratus lumborum blocktransversus abdominis blockpostoperative analgesia

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain

    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

    1 hours

  • Postoperative pain

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

    2 hours

  • Postoperative pain

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

    4 hours

  • The degree of postoperative pain

    The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

    24 hours

Study Arms (3)

Groups Q

EXPERIMENTAL

In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Procedure: trunk blocks

Groups T

EXPERIMENTAL

In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Procedure: trunk blocks

Groups C

NO INTERVENTION

There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients.

Interventions

trunk blocksPROCEDURE

Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery

Groups QGroups T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Abdominal surgery

You may not qualify if:

  • Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaBites and Stings

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Ceyda Ozhan Caparlar

    Diskapi Yildirim Beyazit Education and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Ceyda Ozhan Caparlar, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 29, 2019

Study Start

April 23, 2020

Primary Completion

May 1, 2020

Study Completion

May 5, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04