Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery

NCT01445210 | Completed DMC

• 1 other identifier: 2011-0184
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve. Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve. Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared. The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.

Conditions

Major Ankle Surgery

Keywords

Postoperative pain; Major ankle surgery; Continuous nerve block; Saphenous nerve; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Accumulated opioid consumption

  First 48 hours postoperative

Secondary Outcomes (5)

• Success rate for saphenous nerve analgesia

  Postoperative, first 48 hours

• Success rate for clinical analgesia of foot and ankle

  Postoperative, first 48 hours

• Success rate for tibial and peroneal nerve block

  Postoperative, first 48 hours

• Localisation of worst pain

  Postoperative, first 48 hours

• Cost-effectiveness

  2 first postoperative days

Study Arms (2)

0,2% Ropivacaine

ACTIVE COMPARATOR

Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.

Procedure: Continuous saphenous nerve block

Control

PLACEBO COMPARATOR

Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.

Procedure: Placebo

Interventions

Continuous saphenous nerve block PROCEDURE

0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours

Also known as: Naropin

0,2% Ropivacaine

Placebo PROCEDURE

Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total ankle arthroplasty
• subtalar fusion
• ankle fusion (non arthroscopic)

You may not qualify if:

• coagulation abnormalities
• infection in the region of needle insertion
• systemic infection
• preoperative consumption of high dose opioid
• preoperative sciatic or femoral nerve neuropathy
• preoperative sensory deficit in either of the lower extremities
• Charcot-Marie-Tooth disorder
• diabetic neuropathy
• severe peripheral vascular disease
• allergy to local anesthetics
• lack of understanding of Numeric Rank Scale (NRS)
• communication problems
• dementia
• body mass index above 35
• bilateral continuous sciatic nerve block

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.

  PMID: 25851020 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thomas F Bendtsen, ph.d., MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 3, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

DK (1)