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TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

Primary Purpose

Laparoscopic Renal Surgery, Pain Management, Nerve Block

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

single-injection TQLB(transmuscular quadratus lumborum block)

Morphine given as IPCA(intravenous patient controlled analgesia)

About this trial

This is an interventional supportive care trial for Laparoscopic Renal Surgery

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Cui Xulei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

single-injection TQLB(transmuscular quadratus lumborum block)

Control

Arm Description

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

postoperative IPCA is given alone

Outcomes

Primary Outcome Measures

cumulative morphine consumption 8 hours after surgery

Secondary Outcome Measures

cumulative morphine consumption at other time points 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.

episodes of nausea and vomiting

ambulation time

time from the end of the surgery to the first time to out-of-bed activity

time of recovery of bowl movement

time from the end of the surgery to the first time of bowl movement

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)

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

postoperative length of hospital stay

time to patient's discharge

Full Information

NCT ID

NCT03982784

First Posted

June 4, 2019

Last Updated

November 10, 2019

Sponsor

Cui Xulei

1. Study Identification

Unique Protocol Identification Number

NCT03982784

Brief Title

TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 10, 2019 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

November 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cui Xulei

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Renal Surgery, Pain Management, Nerve Block

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single-injection TQLB(transmuscular quadratus lumborum block)

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

postoperative IPCA is given alone

Intervention Type

Procedure

Intervention Name(s)

single-injection TQLB(transmuscular quadratus lumborum block)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Morphine given as IPCA(intravenous patient controlled analgesia)

Intervention Description

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.

Primary Outcome Measure Information:

Title

cumulative morphine consumption 8 hours after surgery

Time Frame

at the 8 hours after surgery

Secondary Outcome Measure Information:

Title

cumulative morphine consumption at other time points after surgery

Time Frame

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

Title

The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10)

Description

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.

Time Frame

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

Title

episodes of nausea and vomiting

Time Frame

within 24 hours after the surgery

Title

ambulation time

Description

time from the end of the surgery to the first time to out-of-bed activity

Time Frame

within the 5 days after surgery

Title

time of recovery of bowl movement

Description

time from the end of the surgery to the first time of bowl movement

Time Frame

within the 5 days after surgery

Title

patient satisfaction with anesthesia

Description

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)

Time Frame

at 48 hours after surgery

Title

quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale

Description

Time Frame

at 72 hours and 120 hours after the sugery

Title

postoperative length of hospital stay

Description

time to patient's discharge

Time Frame

within 2 weeks after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Cui Xulei

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

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