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

NCT03975296 | Completed

• 1 other identifier: CXL3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Nerve Block, Nephrectomy, Analgesia

Outcome Measures

Primary Outcomes (1)

• cumulative morphine consumption

  within 48 postoperative hours

Secondary Outcomes (8)

• The pain scores determined by the numeric rating scale (NRS, 0-10)

  within 48 postoperative hours

• dermatomal distribution of sensory reduction

  30 min after the block

• quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale

  at 3 days and 5 days after the sugery

• postoperative length of hospital stay

  within 2 weeks after the surgery

• patient satisfaction with anesthesia

  48 hours after surgery

Study Arms (2)

TMQLB group

EXPERIMENTAL

Procedure: preoperative single-shot TMQLB; Drug: patient controlled intravenous analgesia(PCIA)

TPVB group

ACTIVE COMPARATOR

Procedure: preoperative single-shot TPVB; Drug: patient controlled intravenous analgesia(PCIA)

Interventions

preoperative single-shot TMQLB PROCEDURE

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.

TMQLB group

preoperative single-shot TPVB PROCEDURE

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.

TPVB group

patient controlled intravenous analgesia(PCIA) DRUG

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.

TMQLB group; TPVB group

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs American Society of Anesthesiologists physical statusⅠ-Ⅲ Undergo laparoscopic nephrectomy Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cui Xulei: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.

  PMID: 36891030 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• yuguang huang

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The attending physician

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 5, 2019
• Study Start: June 10, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 11, 2021
• Last Updated: July 27, 2021

Record last verified: 2020-03

Locations

CN (1)