TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
Primary Purpose
Nerve Block, Nephrectomy, Analgesia
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TMQLB group 1
TMQLB group 2
TPVB
Sponsored by
About this trial
This is an interventional supportive care trial for Nerve Block, Nephrectomy, Analgesia focused on measuring quadratus lumborum block, thoracic paravertebral block, nephrectomy
Eligibility Criteria
Inclusion Criteria:
- 17~80 years of age;
- American Society of Anesthesiologists physical status I-III;
- undergoing laparoscopic nephrectomy.
Exclusion Criteria:
- have a known allergy to the anesthetics being used;
- infection at injection site
- coagulopathy or history of anticoagulants use
- chronic analgesics consumption or history of substance abuse
- inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).
Sites / Locations
- Xulei CUI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TMQLB group 1
TMQLB group 2
TPVB group
Arm Description
0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.
0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.
0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach.
Outcomes
Primary Outcome Measures
mean VAS of the first postoperative 24 hours
VAS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.
Secondary Outcome Measures
cumulative morphine consumption
morphine consumption will be registered at 0, 2, 4, 8, 12, 24, 48, 72 hours and 7 days after the surgery and will be calculated as the sum of the values
long-term pain control
evaluated by VAS at 48, 72 hours and 7 days after the surgery
dermatomal distribution of sensory loss
evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments
nausea score
pruritus score
ambulation time
time to patient's first walking after the surgery
time of recovery of bowel movement
defined as the time to first flatus
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time
postoperative length of hospital stay
time to patient's discharge
patient satisfaction with anesthesia
evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03414281
Brief Title
TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
Official Title
Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
we use this data as a pilot study
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cui Xulei
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (TPVB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Nephrectomy, Analgesia
Keywords
quadratus lumborum block, thoracic paravertebral block, nephrectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMQLB group 1
Arm Type
Experimental
Arm Description
0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.
Arm Title
TMQLB group 2
Arm Type
Experimental
Arm Description
0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.
Arm Title
TPVB group
Arm Type
Active Comparator
Arm Description
0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach.
Intervention Type
Procedure
Intervention Name(s)
TMQLB group 1
Intervention Description
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Intervention Type
Procedure
Intervention Name(s)
TMQLB group 2
Intervention Description
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Intervention Type
Procedure
Intervention Name(s)
TPVB
Intervention Description
The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Primary Outcome Measure Information:
Title
mean VAS of the first postoperative 24 hours
Description
VAS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.
Time Frame
within the first 24 postoperative hours
Secondary Outcome Measure Information:
Title
cumulative morphine consumption
Description
morphine consumption will be registered at 0, 2, 4, 8, 12, 24, 48, 72 hours and 7 days after the surgery and will be calculated as the sum of the values
Time Frame
at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery
Title
long-term pain control
Description
evaluated by VAS at 48, 72 hours and 7 days after the surgery
Time Frame
at 48, 72 and 7 days after the surgery
Title
dermatomal distribution of sensory loss
Description
evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments
Time Frame
10, 20, 30 and 40 minutes after the intervention
Title
nausea score
Time Frame
at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
Title
pruritus score
Time Frame
at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
Title
ambulation time
Description
time to patient's first walking after the surgery
Time Frame
after the surgery
Title
time of recovery of bowel movement
Description
defined as the time to first flatus
Time Frame
after the surgery
Title
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
Description
QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time
Time Frame
at 3 days and 5 days after the sugery
Title
postoperative length of hospital stay
Description
time to patient's discharge
Time Frame
after the surgery
Title
patient satisfaction with anesthesia
Description
evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery
Time Frame
at 48 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
17~80 years of age;
American Society of Anesthesiologists physical status I-III;
undergoing laparoscopic nephrectomy.
Exclusion Criteria:
have a known allergy to the anesthetics being used;
infection at injection site
coagulopathy or history of anticoagulants use
chronic analgesics consumption or history of substance abuse
inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xulei CUI
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31109368
Citation
Yuan Q, Cui X, Fei Y, Xu Z, Huang Y. Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial. Trials. 2019 May 20;20(1):276. doi: 10.1186/s13063-019-3359-7.
Results Reference
derived
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TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
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