USG Nerve Blocks for ACL Reconstruction

Pain, Postoperative Clinical Trial

Official title:

Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840800
• Other study ID #: H-2-2012-063
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: July 30, 2014
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.

Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.

• ASA 1-3.

• Written and informed consent to study protocol.

Exclusion Criteria:

• ACL reconstruction with patellar tendon graft

• Uncooperative patients.

• Patients that do not understand or speak danish.

• Daily use of opioids equivalent to > 40 mg morphine.

• Allergic to Ropivacaine.

• Alcohol abusers

• Contraindications to general anaesthesia.

• Pregnancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine

• placebo

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, department of anesthesiology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jens Borglum Neimann

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS (pain score)	Numerical rating scale(0-10)	Area under the curve (AUC) 0-6 hours postoperatively	No
Secondary	Opioid consumption	Opioid consumption (PCA pump - mg of morphine)	0-6 hours postoperatively	No
Secondary	opioid related side effects	Nausea (0-3), vomiting (>10 ml)	0-6 hours postoperatively	No
Secondary	PACU time	Minutes in PACU	0-6 hours postoperatively	No
Secondary	Motor abilities of of daily living	Modified Barthel/100 index	0-24 hours postoperatively	No
Secondary	Perceived ill health	Short-Form-8	0-24 hours postoperatively	No
Secondary	Degree of motor block.	Jensen-Borglum motor test	0-6 hours postoperatively	No