Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

NCT02914015 | Terminated

• 1 other identifier: CXL4
• Study Type: interventional
• Target: 40
• 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 and et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Conditions

Hepatectomy; Analgesia; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Cumulative morphine consumption

  at 24 postoperative hours

Secondary Outcomes (8)

• The pain scores determined by the numeric rating scale (NRS, 0-10)

  At 0, 2,4, 8, 12, 24 ,48,72 hours and 7 day after the surgery

• Nausea and Vomiting score

  At 0, 2,4, 8, 12, 24 and 48 hours after the surgery

• Pruritus score

  At 0, 2,4, 8, 12, 24 and 48 hours after the surgery

• Ambulation time

  within the 7 days after surgery

• Time of recovery of bowl movement

  within the 7 days after surgery

Study Arms (2)

Continuous QLB+postoperative IPCA

EXPERIMENTAL

Single-injection of QLB (quadratus lumborum block) is given preoperatively followed with continuous infusion+ postoperative IPCA (intravenous patient control analgesia)

Procedure: Continous QLB (quadratus lumborum block); Device: Philip CX50 Ultrasound Scanner; Drug: Ropivacaine; Drug: Morphine given as IPCA

IPCA

ACTIVE COMPARATOR

Postoperative IPCA (intravenous patient control analgesia) is given alone

Drug: Morphine given as IPCA

Interventions

Continous QLB (quadratus lumborum block) PROCEDURE

Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion

Also known as: Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion

Continuous QLB+postoperative IPCA

Philip CX50 Ultrasound Scanner DEVICE

The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan

Continuous QLB+postoperative IPCA

Ropivacaine DRUG

* 0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline given immediately after the correct position of the tip of the needle has been verified. * followed with 0.2% ropivacaine infusion at a rate of 0.125ml/kg/h given through the catheter inserted in between the quadratus lumborum muscle and psoas major muscle.

Continuous QLB+postoperative IPCA

Morphine given as IPCA DRUG

Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.

Continuous QLB+postoperative IPCA; IPCA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo hepatectomy with right J-shape subcostal incision
• 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)

Xulei CUI

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Catheterization; Ropivacaine; isopropyl cyanoacrylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yuguang Huang, MD.

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: August 1, 2018
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)