TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Laparoscopic Renal Surgery; Nerve Block
• Intervention / Treatment: Procedure: single-injection TQLB(transmuscular quadratus lumborum block); Drug: Morphine given as IPCA(intravenous patient controlled analgesia)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Cui Xulei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion Criteria:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-injection TQLB(transmuscular quadratus lumborum block); Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)	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.
Active Comparator: Control; postoperative IPCA is given alone	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative morphine consumption 8 hours after surgery	at the 8 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative length of hospital stay	time to patient's discharge	within 2 weeks after the surgery
ambulation time	time from the end of the surgery to the first time to out-of-bed activity	within the 5 days after surgery
cumulative morphine consumption at other time points after surgery		at 0, 2, 4, 12, 24 and 48 hours after surgery
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
episodes of nausea and vomiting		within 24 hours after the surgery
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
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
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

Collaborators and Investigators

• Sponsor: Cui Xulei

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 10, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 9, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: cxl2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No