QLB Versus PVB for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy

Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy

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).

Study Overview

• Status: Completed
• Conditions: Nerve Block, Nephrectomy, Analgesia
• Intervention / Treatment: Procedure: preoperative single-shot TMQLB; Drug: patient controlled intravenous analgesia(PCIA); Procedure: preoperative single-shot TPVB

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TPVB group	Drug: patient controlled intravenous analgesia(PCIA); 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.; Procedure: preoperative single-shot TPVB; 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.
EXPERIMENTAL: TMQLB group	Procedure: preoperative single-shot TMQLB; 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.; Drug: patient controlled intravenous analgesia(PCIA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative morphine consumption	within 48 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of recovery of bowl movement		within the 5 days after surgery
patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery
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.	within 48 postoperative hours
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.	30 min after the 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	at 3 days and 5 days after the sugery
postoperative length of hospital stay	time to patient's discharge	within 2 weeks after the surgery
nausea and vomiting episodes		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

Collaborators and Investigators

• Sponsor: Cui Xulei

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2019
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): January 11, 2021

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 25, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: CXL3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No