TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

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 Renal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03414281
• Other study ID #: cuixulei5
• Status: Terminated
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: May 1, 2019

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 renal surgery compared with thoracic paravertebral block (TPVB).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

• 17~80 years of age;

• American Society of Anesthesiologists physical status I-III;

• undergoing laparoscopic nephrectomy.

Exclusion Criteria:

• have a known allergy to the anesthetics being used;

• infection at injection site

• coagulopathy or history of anticoagulants use

• chronic analgesics consumption or history of substance abuse

• inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).

Related Conditions & MeSH terms

• Acute Pain
• Nerve Block, Nephrectomy, Analgesia

Intervention

Procedure:
• TMQLB group 1
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 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. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline 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 2
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 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 with 1: 200,000 adrenaline 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.
• 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 linear(L12-3) probe of Philips CX50 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 with 1: 200,000 adrenaline is injected into the paravertebral space of T10. 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.

Locations

Country	Name	City	State
China	Xulei CUI	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Xulei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean VAS of the first postoperative 24 hours	VAS 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. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.	within the first 24 postoperative hours
Secondary	cumulative morphine consumption	morphine consumption will be registered at 0, 2, 4, 8, 12, 24, 48, 72 hours and 7 days after the surgery and will be calculated as the sum of the values	at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery
Secondary	long-term pain control	evaluated by VAS at 48, 72 hours and 7 days after the surgery	at 48, 72 and 7 days after the surgery
Secondary	dermatomal distribution of sensory loss	evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments	10, 20, 30 and 40 minutes after the intervention
Secondary	nausea score		at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
Secondary	pruritus score		at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
Secondary	ambulation time	time to patient's first walking after the surgery	after the surgery
Secondary	time of recovery of bowel movement	defined as the time to first flatus	after the surgery
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	after the surgery
Secondary	patient satisfaction with anesthesia	evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery	at 48 hours after the surgery