QLB Versus PVB for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy
Primary Purpose
Nerve Block, Nephrectomy, Analgesia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
preoperative single-shot TMQLB
preoperative single-shot TPVB
patient controlled intravenous analgesia(PCIA)
Sponsored by
About this trial
This is an interventional supportive care trial for Nerve Block, Nephrectomy, Analgesia
Eligibility Criteria
Inclusion Criteria:
Age 18-70 yrs American Society of Anesthesiologists physical statusⅠ-Ⅲ Undergo laparoscopic nephrectomy Informed consent
Exclusion Criteria:
A known allergy to the drugs being used Coagulopathy, on anticoagulants Analgesics intake, history of substance abuse Participating in the investigation of another experimental agent Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TMQLB group
TPVB group
Arm Description
Outcomes
Primary Outcome Measures
cumulative morphine consumption
Secondary Outcome Measures
The pain scores determined by the numeric rating scale (NRS, 0-10)
NRS 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.
dermatomal distribution of sensory reduction
Thirty minutes after the block, the bilateral dermatomal sensory blocks for the anterior abdomen (between the anterior axillary and mid-clavicular lines) and thigh were assessed with the pinprick method. A reduce in pinprick sensation relative to the unblocked side was interpreted as an effective block.
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
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia
nausea and vomiting episodes
ambulation time
time from the end of the surgery to the first time to out-of-bed activity
time of recovery of bowl movement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03975296
Brief Title
QLB Versus PVB for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy
Official Title
Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 11, 2021 (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 partial nephrectomy 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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMQLB group
Arm Type
Experimental
Arm Title
TPVB group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
preoperative single-shot TMQLB
Intervention Description
The patient is placed in the lateral position. The curved probe of 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 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)
preoperative single-shot 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 curve probe of ultrasound scanner 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 is injected into the paravertebral space of T10.
Intervention Type
Drug
Intervention Name(s)
patient controlled intravenous analgesia(PCIA)
Intervention Description
at the end of surgery, patient is administered a PCIA with morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
Primary Outcome Measure Information:
Title
cumulative morphine consumption
Time Frame
within 48 postoperative hours
Secondary Outcome Measure Information:
Title
The pain scores determined by the numeric rating scale (NRS, 0-10)
Description
NRS 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.
Time Frame
within 48 postoperative hours
Title
dermatomal distribution of sensory reduction
Description
Thirty minutes after the block, the bilateral dermatomal sensory blocks for the anterior abdomen (between the anterior axillary and mid-clavicular lines) and thigh were assessed with the pinprick method. A reduce in pinprick sensation relative to the unblocked side was interpreted as an effective block.
Time Frame
30 min after the block
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
within 2 weeks after the surgery
Title
patient satisfaction with anesthesia
Description
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia
Time Frame
48 hours after surgery
Title
nausea and vomiting episodes
Time Frame
within 24 hours after the surgery]
Title
ambulation time
Description
time from the end of the surgery to the first time to out-of-bed activity
Time Frame
within the 5 days after surgery
Title
time of recovery of bowl movement
Time Frame
within the 5 days after 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:
Age 18-70 yrs American Society of Anesthesiologists physical statusⅠ-Ⅲ Undergo laparoscopic nephrectomy Informed consent
Exclusion Criteria:
A known allergy to the drugs being used Coagulopathy, on anticoagulants Analgesics intake, history of substance abuse Participating in the investigation of another experimental agent Inability to properly describe postoperative pain to investigators (eg, 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
Peking Union Medical College Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
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QLB Versus PVB for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy
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