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

Nerve Block, Nephrectomy, Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975296
• Other study ID #: CXL3
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: March 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 11, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

Age 18-70 yrs American Society of Anesthesiologists physical status?-? 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)

Related Conditions & MeSH terms

• Acute Pain
• Nerve Block, Nephrectomy, Analgesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Xulei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative morphine consumption		within 48 postoperative hours
Secondary	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
Secondary	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
Secondary	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
Secondary	postoperative length of hospital stay	time to patient's discharge	within 2 weeks after the surgery
Secondary	patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery
Secondary	nausea and vomiting episodes		within 24 hours after the surgery]
Secondary	ambulation time	time from the end of the surgery to the first time to out-of-bed activity	within the 5 days after surgery
Secondary	time of recovery of bowl movement		within the 5 days after surgery