NCT03942237

Brief Summary

This prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

May 7, 2019

Last Update Submit

December 31, 2019

Conditions

Pain ManagementNerve BlockLaparoscopic Adrenalectomy

Keywords

transmuscular quadratus lumborum blockadrenalectomy

Outcome Measures

Primary Outcomes (1)

  • the NRS pain scores on activity 12-hours after surgery

    The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool

    12-hours after surgery

Secondary Outcomes (7)

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

    At 2,4, 8, 12, 24 ,48,72 hours after the surgery

  • incidence of postoperative nausea and vomiting (PONV)

    within 24 postoperative hours

  • ambulation time

    within 5 days after surgery

  • time of recovery of bowel movement

    within 5 days after surgery

  • postoperative length of hospital stay

    up to 2 weeks after surgery

  • +2 more secondary outcomes

Study Arms (2)

single-injection QLB (quadratus lumborum block)

EXPERIMENTAL

Single-injection of QLB with local anesthetic is given preoperatively

Procedure: single-injection QLB(quadratus lumborum block)

Placebo control

PLACEBO COMPARATOR

Single-injection of QLB with NS is given preoperatively

Procedure: Placebo Control

Interventions

single-injection QLB(quadratus lumborum block)PROCEDURE

Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major muscle Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine is given immediately after the correct position of needle tip is verified.

single-injection QLB (quadratus lumborum block)
Placebo ControlPROCEDURE

Inject 0.4ml/kg saline between quadratus lumborum and psoas major muscle Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan Drug: single dose 0.4ml/kg 0.9% NS is given immediately after the correct position of the needle tip is verified

Placebo control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • a known allergy to the medications being used for anesthesia
  • coagulopathy or on anticoagulants
  • chronic opioid therapy or history of substance abuse
  • participating in another RCT
  • inability to properly describe postoperative pain to investigators (e.g., language barrier, neuropsychiatric disorder).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

  • Yuan Q, Lu S, Cui X, Zhang Y, Xie Y, Zhang Y, Yan W, Ji Z, Huang Y. Transmuscular quadratus lumborum block for postoperative pain and recovery after laparoscopic adrenalectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Nov 9;21(1):274. doi: 10.1186/s12871-021-01494-4.

    PMID: 34753425DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yuguang Huang

    PUMCH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 8, 2019

Study Start

May 10, 2019

Primary Completion

August 28, 2019

Study Completion

September 2, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

CN(1)