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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05001802
Other study ID # 20210505
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 20, 2021
Est. completion date December 1, 2021

Study information

Verified date November 2021
Source Peking Union Medical College Hospital
Contact Xulei MD Cui
Phone +8613717739381
Email cuixulei10685@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our objective is to investigate the extent of cranial dermatomal spread of transmuscular quadratus lumborum block(TMQLB )when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy.


Description:

The paramedian sagittal oblique transmuscular quadratus lumborum block(TMQLB )approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction compared with the transverse approach. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread level. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2021
Est. primary completion date November 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =Age 18yrs - American Society of Anesthesiologists physical status I-II - Undergo laparoscopic adrenalectomy - Informed consent - Able to cooperate with study process Exclusion Criteria: - Allergy to local anesthetic and other medications used in the study - Patient refusal or lack of informed consent - Coexisting hematological disorder or with deranged coagulation parameters - Pre-existing major organ dysfunction such as hepatic and renal failure - History of previous renal surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
transverse scan, in-plane, posterior- anterior quadratus lumborum block
transverse scan, in-plane, posterior- anterior quadratus lumborum block The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block
The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cephalic sensory dermatomal spread The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The most cephalic dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block. 20 minutes after block performance]
Secondary Time to performance of procedure Duration from needle insertion toward local anesthetic injection finished Duration of procedure
Secondary Total sensory dermatomal spread The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The total number of dermatomal levels that show decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block. 20 minutes after block performance
Secondary Incidence of complication incidence of complication including bleeding, hematoma, infection at puncture site, local anesthetic poisoning, etc Within 48 hours after surgery
Secondary Caudal sensory dermatomal spread The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The most caudal dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block. 20 minutes after block performance
Secondary rescue analgesics usage NSAIDs or opioids used for pain relief and their dosage At 0,12,24,48 hours after surgery
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