TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
Primary Purpose
Laparoscopic Renal Surgery, Pain Management, Nerve Block
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single-injection TQLB(transmuscular quadratus lumborum block)
Morphine given as IPCA(intravenous patient controlled analgesia)
Sponsored by
About this trial
This is an interventional supportive care trial for Laparoscopic Renal Surgery
Eligibility Criteria
inclusion Criteria:
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic partial 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
- Cui Xulei
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single-injection TQLB(transmuscular quadratus lumborum block)
Control
Arm Description
Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)
postoperative IPCA is given alone
Outcomes
Primary Outcome Measures
cumulative morphine consumption 8 hours after surgery
Secondary Outcome Measures
cumulative morphine consumption at other time points after surgery
The pain scores(at rest or on activity) 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.
episodes of nausea and vomiting
ambulation time
time from the end of the surgery to the first time to out-of-bed activity
time of recovery of bowl movement
time from the end of the surgery to the first time of bowl movement
patient satisfaction with anesthesia
Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03982784
Brief Title
TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
Official Title
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 10, 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
5. Study Description
Brief Summary
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay,et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic partial nephrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Renal Surgery, Pain Management, Nerve Block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-injection TQLB(transmuscular quadratus lumborum block)
Arm Type
Experimental
Arm Description
Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
postoperative IPCA is given alone
Intervention Type
Procedure
Intervention Name(s)
single-injection TQLB(transmuscular quadratus lumborum block)
Intervention Description
Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance
Intervention Type
Drug
Intervention Name(s)
Morphine given as IPCA(intravenous patient controlled analgesia)
Intervention Description
PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.
Primary Outcome Measure Information:
Title
cumulative morphine consumption 8 hours after surgery
Time Frame
at the 8 hours after surgery
Secondary Outcome Measure Information:
Title
cumulative morphine consumption at other time points after surgery
Time Frame
at 0, 2, 4, 12, 24 and 48 hours after surgery
Title
The pain scores(at rest or on activity) 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
at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery
Title
episodes of nausea and vomiting
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
Description
time from the end of the surgery to the first time of bowl movement
Time Frame
within the 5 days after surgery
Title
patient satisfaction with anesthesia
Description
Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
Time Frame
at 48 hours after 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 72 hours and 120 hours after the sugery
Title
postoperative length of hospital stay
Description
time to patient's discharge
Time Frame
within 2 weeks 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:
Age 18-70 yrs
American Society of Anesthesiologists physical statusⅠ-Ⅲ
Undergo laparoscopic partial 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)
Facility Information:
Facility Name
Cui Xulei
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
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