Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery

Anesthesia Clinical Trial

— Liga-PACK  

Official title:

Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05136352
• Other study ID #: RC31/21/0167
• Secondary ID: 2021-A01226-35
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.

Description:

The ideal loco-regional anesthesia for anterior cruciate ligament reconstruction ensuring a satisfying analgesia without compromising an early rehabilitation is still undetermined. Femoral nerve block has been incriminated in a delayed postoperative mobilization whereas the adductor canal block gives an equivalent analgesia for a better preservation of the quadricipital muscular strength. The iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) is a recently described technique. Few studies have assessed the iPACK block in ACL reconstruction, and none were randomized. This randomized single blind clinical trial compares two groups of 45 patients who undergo ACL reconstruction surgery under general anaesthetic : one receives an iPACK block associated with an adductor canal block, and the other only has an adductor canal block. Pain scores and opioid consumption are collected after surgery in the recovery room, then by telephone interview at 24 and 48 hours post-surgery. Functional rehabilitation is evaluated by scales (KOOS, LYSHOLM and iKDC) at 3, 6 and 9 months after surgery. Adverse effects, due to anesthesia or opioids, are collected from 30 min after loco-regional anesthesia until the second phone call at 48h post-surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• ACL repair surgery under general anesthesia
• Person affiliated or beneficiary of a social security plan
• Free, informed and written consent

Exclusion Criteria:

• Age < 18 years
• Contraindication to ALR (allergy to local anesthetics, local infection of the puncture site, coagulopathy)
• Pre-existing opiate dependence
• Contraindication to non-steroidal anti-inflammatory drugs
• Pregnant or potentially pregnant women
• Patients under the protection of adults (guardianship, curatorship or safeguard of justice)
• Patients whose cognitive state does not allow evaluation by the scales used

Related Conditions & MeSH terms

• Anesthesia
• Anterior Cruciate Ligament Reconstruction

Intervention

Procedure:
• adductor canal block
loco-regional anesthesia using adductor canal block
• iPACK block
loco-regional anesthesia using infiltration between the popliteal artery and the capsule of the posterior knee

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption at 48 hours after surgery	Cumulative opioid consumption in the first 48 hours after anterior cruciate ligament repair surgery	Hours 48
Secondary	Cumulative opioid consumption at 2 hours after surgery	Cumulative opioid consumption in the recovery room after anterior cruciate ligament repair surgery	Hours 2
Secondary	Cumulative opioid consumption at 24 hours after surgery	Cumulative opioid consumption in the first 24 hours after anterior cruciate ligament repair surgery	Hours 24
Secondary	Cumulative opioid consumption at 3 months	total opioid consumption at 3 months after anterior cruciate ligament repair surgery	month 3
Secondary	Maximum pain score in the recovery room	Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)	hours 2
Secondary	Maximum pain score at 24 hours after surgery	Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)	hours 24
Secondary	Maximum pain score at 48 hours after surgery	Maximum pain score evaluated by the numerical pain scale from 0 to 10 (0 lowest pain score / 10 highest pain score)	hours 48