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Completed

NCT Number: NCT03975296

QLB Versus PVB 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).

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Key information

Conditions

Nerve Block, Nephrectomy, Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. cumulative morphine consumption

    Time frame: within 48 postoperative hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cui Xulei

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2019
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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