TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

NCT03982784 | Completed

• 1 other identifier: cxl2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Renal Surgery; Pain Management; Nerve Block

Outcome Measures

Primary Outcomes (1)

• cumulative morphine consumption 8 hours after surgery

  at the 8 hours after surgery

Secondary Outcomes (8)

• 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)

  at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery

• episodes of nausea and vomiting

  within 24 hours after the surgery

• ambulation time

  within the 5 days after surgery

• time of recovery of bowl movement

  within the 5 days after surgery

Study Arms (2)

single-injection TQLB(transmuscular quadratus lumborum block)

EXPERIMENTAL

Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)

Procedure: single-injection TQLB(transmuscular quadratus lumborum block); Drug: Morphine given as IPCA(intravenous patient controlled analgesia)

Control

ACTIVE COMPARATOR

postoperative IPCA is given alone

Drug: Morphine given as IPCA(intravenous patient controlled analgesia)

Interventions

single-injection TQLB(transmuscular quadratus lumborum block) PROCEDURE

Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance

single-injection TQLB(transmuscular quadratus lumborum block)

Morphine given as IPCA(intravenous patient controlled analgesia) DRUG

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.

Control; single-injection TQLB(transmuscular quadratus lumborum block)

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo laparoscopic partial nephrectomy
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cui Xulei: lead

Study Sites (1)

Cui Xulei

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 12, 2019
• Study Start: June 10, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 10, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

CN (1)