Quadratus lumborum 3 block (QLB3) for laparoscopic colorectal surgery: A double blind, prospective randomized placebo-controlled trial.

Quadratus lumborum 3 block (QLB3) for laparoscopic colorectal surgery: A double blind, prospective randomized placebo-controlled trial. - QLB 3 for laparoscopic colorectal surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002304-40-BE

Enrollment

150

Registered

2019-08-08

Start date

2019-09-17

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain

Interventions

Trade Name: Naropin Pharmaceutical Form: Solution for injection INN or Proposed INN: Naropin CAS Number: 132112-35-7 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18-75 years of age - BMI = 35 - Patient is able to give informed consent - Patient understands the use of morphine PCIA - Patient is scheduled for elective laparoscopic colorectal surgery - ASA I-III Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: - Refusal to participate in the trial - Inability to operate a PCIA system - Chronic opioid use - Patient has moderate to severe kidney failure (GFR < 44 mL/min) - Patient has acute or chronic liver insufficiency as defined by: ? Bilirubine (µmol/l) = 34 ? Albumine (g/l) = 35 INR<=1.7

Design outcomes

Primary

Measure	Time frame
Secondary Objective: not applecable;Main Objective: The goal of this study is to improve pain management, minimize the need for postoperative opioids and to facilitate postoperative recovery after laparoscopic colorectal surgery. Our hypothesis is that a bilateral single shot QLB 3 block with 30mL ropivacaine 0,375% on each side is associated with a reduction in postoperative morphine consumption as compared to normal saline 0,9%. Superiority of the QLB 3 block will be defined as a 30% reduction in the cumulative 24-hour morphine consumption post-surgery.;Primary end point(s): cumulative 24-hour morphine consumption;Timepoint(s) of evaluation of this end point: 24 hours after start PCIA pump	—

Measure

Time frame

Secondary Objective: not applecable;Main Objective: The goal of this study is to improve pain management, minimize the need for postoperative opioids and to facilitate postoperative recovery after laparoscopic colorectal surgery. Our hypothesis is that a bilateral single shot QLB 3 block with 30mL ropivacaine 0,375% on each side is associated with a reduction in postoperative morphine consumption as compared to normal saline 0,9%. Superiority of the QLB 3 block will be defined as a 30% reduction in the cumulative 24-hour morphine consumption post-surgery.;Primary end point(s): cumulative 24-hour morphine consumption;Timepoint(s) of evaluation of this end point: 24 hours after start PCIA pump

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Secondary

Measure	Time frame
Secondary end point(s): Pain intensity as assessed with the numerical rating score for pain Extent of motor block extent of sensory block incidence of adverse events during treatment ; Timepoint(s) of evaluation of this end point: NRS Pain: every 15 min after arrival in the PACU until +120 min, 2h, 3h, 4h and 24h postoperative Extent of motor and sensory block 1h, 2h, 3h and 4h after arrival in the PACU Patient satisfaction score 24h post surgery. Incidence of adverse events: continuously until 24h post operative	—

Measure

Time frame

Secondary end point(s): Pain intensity as assessed with the numerical rating score for pain Extent of motor block extent of sensory block incidence of adverse events during treatment ; Timepoint(s) of evaluation of this end point: NRS Pain: every 15 min after arrival in the PACU until +120 min, 2h, 3h, 4h and 24h postoperative Extent of motor and sensory block 1h, 2h, 3h and 4h after arrival in the PACU Patient satisfaction score 24h post surgery. Incidence of adverse events: continuously until 24h post operative

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Countries

Belgium

Contacts

Public Contactanesthesiology research

University hospitals Leuven

christel.huygens@uzleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026