Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

Pain Management Clinical Trial

Official title:

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942237
• Other study ID #: cuixulei8
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: September 2, 2019

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 yrs

• American Society of Anesthesiologists physical status?-?

• Undergo laparoscopic adrenalectomy

• Informed consent

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Laparoscopic Adrenalectomy
• Nerve Block
• Pain Management
• Pain, Postoperative

Intervention

Procedure:
• single-injection QLB(quadratus lumborum block)
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.
• Placebo Control
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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the pain scores at rest determined by the numeric rating scale (NRS, 0-10)	The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool	At 2,4, 8, 12, 24 ,48,72 hours after the surgery
Secondary	incidence of postoperative nausea and vomiting (PONV)		within 24 postoperative hours
Secondary	ambulation time		within 5 days after surgery
Secondary	time of recovery of bowel movement	defined as the time to first flatus	within 5 days after surgery
Secondary	postoperative length of hospital stay		up to 2 weeks after surgery
Secondary	patient's satisfaction of anesthesia and analgesia	use the Chinese version of Bauer questionnaire to assess the patient satisfaction of anesthesia	48 hours after surgery
Secondary	the NRS pain scores on activity after surgery	The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool	At 2,4, 8, 24 ,48,72 hours after the surgery