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

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ClinicalTrials.gov Identifier: NCT03975296
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Xulei, Peking Union Medical College Hospital

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).

Condition or disease Intervention/treatment Phase
Nerve Block, Nephrectomy, Analgesia Procedure: preoperative single-shot TMQLB Procedure: preoperative single-shot TPVB Drug: patient controlled intravenous analgesia(PCIA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Partial Nephrectomy
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 15, 2019

Arm Intervention/treatment
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.

Active Comparator: TPVB group 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.

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.




Primary Outcome Measures :
  1. cumulative morphine consumption [ Time Frame: within 48 postoperative hours ]

Secondary Outcome Measures :
  1. The pain scores determined by the numeric rating scale (NRS, 0-10) [ Time Frame: within 48 postoperative hours ]
    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.

  2. dermatomal distribution of sensory reduction [ Time Frame: 30 min after the block ]
    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.

  3. quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale [ Time Frame: at 3 days and 5 days after the sugery ]
    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

  4. postoperative length of hospital stay [ Time Frame: within 2 weeks after the surgery ]
    time to patient's discharge

  5. patient satisfaction with anesthesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia

  6. nausea and vomiting episodes [ Time Frame: within 24 hours after the surgery] ]
  7. ambulation time [ Time Frame: within the 5 days after surgery ]
    time from the end of the surgery to the first time to out-of-bed activity

  8. time of recovery of bowl movement [ Time Frame: within the 5 days after surgery ]


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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975296


Contacts
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Contact: xulei cui +86 13717739381 cui.xulei@aliyun.com
Contact: yuguang huang +86-010-69152030 garybeijing@163.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Xulei CUI, MD    +8613717739381    cui.xulei@aliyun.com   
Contact: Yuguang Huang, MD         
Sponsors and Collaborators
Cui Xulei
Investigators
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Study Chair: yuguang huang Peking Union Medical College Hospital

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Responsible Party: Cui Xulei, The attending physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03975296     History of Changes
Other Study ID Numbers: CXL3
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms