TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

Study Overview
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Brief Summary
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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).

Official Title
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Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

Conditions
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Nerve Block, Nephrectomy, Analgesia

Intervention / Treatment
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* Procedure: TMQLB group 1
* Procedure: TMQLB group 2
* Procedure: TPVB


Participation Criteria
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Eligibility Criteria
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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).

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMQLB group 1<br>0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. | Procedure: TMQLB group 1<br>* 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.<br>|
| Experimental: TMQLB group 2<br>0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. | Procedure: TMQLB group 2<br>* 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.<br>|
| Active Comparator: TPVB group<br>0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach. | Procedure: TPVB<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within the first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery | 
| long-term pain control | evaluated by VAS at 48, 72 hours and 7 days after the surgery | at 48, 72 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 | 10, 20, 30 and 40 minutes after the intervention | 
| nausea score |  | at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery; | 
| pruritus score |  | at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery; | 
| ambulation time | time to patient's first walking after the surgery | after the surgery | 
| time of recovery of bowel movement | defined as the time to first flatus | after the 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 3 days and 5 days after the sugery | 
| postoperative length of hospital stay | time to patient's discharge | after the surgery | 
| patient satisfaction with anesthesia | evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery | at 48 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadratus lumborum block, thoracic paravertebral block, nephrectomy