TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

Study Overview
=================
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.

Official Title
-----------------
Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial

Conditions
-----------------
Laparoscopic Renal Surgery, Pain Management, Nerve Block

Intervention / Treatment
-----------------
* Procedure: single-injection TQLB(transmuscular quadratus lumborum block)
* Drug: Morphine given as IPCA(intravenous patient controlled analgesia)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-injection TQLB(transmuscular quadratus lumborum block)<br>Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia) | Procedure: single-injection TQLB(transmuscular quadratus lumborum block)<br>* Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance<br>Drug: Morphine given as IPCA(intravenous patient controlled analgesia)<br>* 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.<br>|
| Active Comparator: Control<br>postoperative IPCA is given alone | Drug: Morphine given as IPCA(intravenous patient controlled analgesia)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative morphine consumption 8 hours after surgery |  | at the 8 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative morphine consumption at other time points after surgery |  | at 0, 2, 4, 12, 24 and 48 hours 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. | at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery | 
| episodes of nausea and vomiting |  | within 24 hours after the surgery | 
| ambulation time | time from the end of the surgery to the first time to out-of-bed activity | within the 5 days after surgery | 
| time of recovery of bowl movement | time from the end of the surgery to the first time of bowl movement | within the 5 days after surgery | 
| 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) | at 48 hours after surgery | 
| 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 | at 72 hours and 120 hours after the sugery | 
| postoperative length of hospital stay | time to patient's discharge | within 2 weeks after the surgery |