TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

Pain Management Clinical Trial

Official title:

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982784
• Other study ID #: cxl2
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: November 10, 2019

Study information

• Verified date: November 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic partial nephrectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 10, 2019
• Est. primary completion date: November 1, 2019
• 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 partial 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

• Laparoscopic Renal Surgery
• Nerve Block
• Pain Management
• Pain, Postoperative

Intervention

Procedure:
• single-injection TQLB(transmuscular quadratus lumborum block)
Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance

Drug:
• Morphine given as IPCA(intravenous patient controlled analgesia)
PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.

Locations

Country	Name	City	State
China	Cui Xulei	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	cumulative morphine consumption 8 hours after surgery		at the 8 hours after surgery
Secondary	cumulative morphine consumption at other time points after surgery		at 0, 2, 4, 12, 24 and 48 hours after surgery
Secondary	The pain scores(at rest or on activity) 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.	at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery
Secondary	episodes of nausea and vomiting		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	time from the end of the surgery to the first time of bowl movement	within the 5 days after surgery
Secondary	patient satisfaction with anesthesia	Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)	at 48 hours after 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 72 hours and 120 hours after the sugery
Secondary	postoperative length of hospital stay	time to patient's discharge	within 2 weeks after the surgery