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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03693222
Other study ID # BakirkoySadiKonuk
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2016
Est. completion date November 15, 2016

Study information

Verified date August 2018
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Quadratus lumborum block (QLB) is a newly-defined trunk block performed with local anesthetic injection by imaging the abdominal muscles with ultrasonography (US) guidance; thus, analgesia is expected to be ensured from the T7-L1 dermatomal segment level.

In the study, the aim was to compare the postoperative analgesic effect of quadratus lumborum block in pediatric patients undergoing lower abdominal surgery


Description:

Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).

Total analgesic amounts in 24 hours and first analgesic requirement times recorded.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 15, 2016
Est. primary completion date November 15, 2016
Accepts healthy volunteers No
Gender All
Age group 3 Years to 16 Years
Eligibility Inclusion Criteria:

- The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with ASA (American Society of Anesthesiologist) I-II level.

Exclusion Criteria:

- Cases with ASA III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tramadol Hydrochloride
The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score =3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing =3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.
Morphine Sulfate
The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score =3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing =3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative total analgesic amounts in 24 hours the number of analgesic requirements how many times in 24 hours
Secondary first analgesic requirement times first analgesic requirement times (hours) in 24 hours
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