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

Phase 4

Completed

• Conditions: Postoperative Pain; Ultrasound Guided Transmuscular Quadratus Lumborum Block
• Interventions: Drug: Ropivacaine; Drug: Saline

• Registration Number: NCT03571490
• Lead Sponsor: Zealand University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-27
• Study Start: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQL Ropivacaine(active)	Ropivacaine	Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine
TQL saline (placebo)	Saline	Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%

Primary Outcome Measures

Name	Time	Method
opioid consumption	12 hours postoperatively	Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zealand university Hospital, Anaesthesiology; 🇩🇰 Roskilde, Denmark