Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy

This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

Study Overview

• Status: Terminated
• Conditions: Pain Management; Nerve Block; Laparoscopic Adrenalectomy
• Intervention / Treatment: Procedure: single-injection QLB(quadratus lumborum block); Procedure: Placebo control

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (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 adrenalectomy
• 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control; Single-injection of QLB with NS is given preoperatively	Procedure: Placebo control; Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.
Experimental: single-injection QLB(quadratus lumborum block); Single-injection of QLB with local anesthetic is given preoperatively	Procedure: single-injection QLB(quadratus lumborum block); Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery	At 12hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative nausea and vomiting (PONV)		within 24 postoperative hours
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)		At 2,4, 8, 12,24 ,48,72hours after the surgery
ambulation time		within5 days after surgery
time of restart anal exhaust		within 5 days after surgery
Postoperative length of hospital stay		up to2 weeks after surgery
patient's satisfaction with anesthesia and analgesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia	48 hours after surgery
The pain scores at activity determined by the numeric rating scale (NRS, 0-10)		At 2,4, 8, 24 ,48,72hours after the surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2019
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: cuixulei6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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