Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

Postoperative Pain Clinical Trial

Official title:

Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571490
• Other study ID #: V2.02.05.2017
• Secondary ID: 2017-002130-23
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2018
• Est. completion date: June 24, 2019

Study information

• Verified date: March 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 years

• Kidney cancer

• Have received thorough information, orally and in written

• Signed the "Informed Consent" form on participation in the trial

Exclusion Criteria:

• Inability to cooperate

• Inability to speak and understand Danish both orally and written

• Allergy to local anaesthetics or opioids

• Daily intake of opioids

• Local infection at the site of injection or systemic infection

• Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration

• Known abuse of alcohol or medicine

• Pregnancy

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Ultrasound Guided Transmuscular Quadratus Lumborum Block

Intervention

Drug:
• Ropivacaine
Single shot of ropivacaine 0.325%
• Saline
Single shot of saline 0.9%

Locations

Country	Name	City	State
Denmark	Zealand university Hospital, Anaesthesiology	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption	Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).	12 hours postoperatively
Secondary	opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	6 hours postoperatively
Secondary	opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	18 hours postoperatively
Secondary	opioid consumption	Opioid consumption postoperatively (data from PCA pump and patient medical record).	24 hours postoperatively
Secondary	NRS score	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity	12 hours postoperatively
Secondary	NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	6 hours postoperatively
Secondary	NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	18 hours postoperatively
Secondary	NRS score at rest and activity	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	24 hours postoperatively
Secondary	Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	6 hours postoperatively
Secondary	Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	12 hours postoperatively
Secondary	Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	18 hours postoperatively
Secondary	Opioid-related side effects	The degree of morphine-related side effects (PONV, itching, fatigue, etc.)	24 hours postoperatively
Secondary	Patient satisfaction with application of the block. NRS	Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain	Immediately after application of the block
Secondary	Ambulation	Time from operation to ambulation	within 24 hours postoperatively