Study of Pain Management Techniques Following Anterior Cruciate Ligament Repair Surgery

NCT01868282 | Completed Phase 2

• 1 other identifier: 103681
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Patients scheduled to undergo knee arthroscopy with anterior cruciate ligament repair with graft from the ipsilateral hamstrings and gracilis will be randomized to one of three groups. All patients will receive subsartorial saphenous nerve block. Along with this, Group 1 will receive perihamstring local anesthetic infiltration (Hamstring block), Group 2 will receive blockade of the anterior division of obturator nerve and Group 3 (control group) will receive sham injections of hamstrings and anterior division obturator nerve. All patients will receive co-analgesics for home discharge. The study will evaluate the efficacy of subsartorial saphenous nerve block alone or in combination with either hamstring block or obturator block with regards to postoperative analgesia especially the donor site pain and total analgesic consumption.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

anterior cruciate ligament repair, Obturator nerve block, Hamstrings graft, Ropivacaine,; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain scores at admission to PACU

  The primary outcome will be post-operative pain scores at I hour after arrival in PACU.

  Baseline

Secondary Outcomes (1)

• Pain scores at 4 hours of arrival to PACU

  4 hours

Other Outcomes (1)

• first 24 pain scores

  Day1

Study Arms (3)

Group 1

EXPERIMENTAL

Hamstrings block

Procedure: Hamstrings block

Group 2

ACTIVE COMPARATOR

Obturator block

Procedure: Obturator block

Group 3

SHAM COMPARATOR

Control group

Procedure: Control group

Interventions

Hamstrings block PROCEDURE

patients enrolled in the study will receive subsartorial saphenous nerve block in all the three groups. Patients in group 1 will receive perimuscular injections around the gracilis and semi-tendinosus muscles. The needle is redirected to the fascial plane between Sartorius and gracilis muscle after the sub-sartorial canal block where 7.5 ml of 0.5% ropivacaine is injected around the muscle. The needle is further advanced to the fascial planes between semimembranosus and semitendinosus and an additional 7.5 ml of 0.5% ropivacaine will be injected around the semitendinosus muscle. Following this a sham injection of 10mL of saline for the anterior division of obturator nerve will also be performed as in group 2 to ensure blinding.

Also known as: perimuscular injections

Group 1

Obturator block PROCEDURE

Patients in group 2 will receive anterior division of obturator nerve block along with subsartorial canal block. After ensuring aseptic precautions, the saphenous nerve block is performed similar to that as in group 1. The anterior branch of obturator nerve will be visualised in the proximal thigh medial to femoral vessels between adductor longus and adductor brevis. A 22 gauge 90 mm PNS block needle will be inserted under ultrasound guidance to reach the anterior division of obturator nerve confirmed with neurostimulation followed by injection of 10 ml of 0.5% ropivacaine around the nerve. This group will receive sham injection of 15mL of saline around semitendinosus and semimembranosus as in group 1

Also known as: anterior division obturator nerve block

Group 2

Control group PROCEDURE

The patients in group 3 will form the control group. After performance of the subsartorial saphenous nerve block, patients in group 3 will receive sham injections of saline for the obturator nerve block and the hamstrings block (perimuscular injections).

Also known as: saline group

Group 3

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and females of 16-85years of age, scheduled to undergo anterior cruciate ligament repair with ipsilateral hamstrings graft.
• ASA Class I-III

You may not qualify if:

• ASA 4
• Revision surgery
• Graft harvest from the contralateral hamstrings or allograft
• Narcotic dependent (opioid intake more than 3 months) or any chronic pain conditions
• Patients with associated significant cardiac and respiratory disease
• Patients with coexisting hematological disorder or with deranged coagulation parameters.
• Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
• Psychiatric illnesses
• Emergency surgery
• Lack of informed consent.
• Allergy to any of the drugs used in the study
• Preoperative neurological deficits

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

University Hospital, London Health Sciences Center,

London, Ontario, N6A 5A5, Canada

Location

Related Publications (5)

• Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13.

  PMID: 20620788 BACKGROUND

• Saranteas T, Anagnostis G, Paraskeuopoulos T, Koulalis D, Kokkalis Z, Nakou M, Anagnostopoulou S, Kostopanagiotou G. Anatomy and clinical implications of the ultrasound-guided subsartorial saphenous nerve block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):399-402. doi: 10.1097/AAP.0b013e318220f172.

  PMID: 21697687 BACKGROUND

• Lundblad M, Forssblad M, Eksborg S, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block for anterior cruciate ligament repair: a prospective, randomised, double-blind, placebo-controlled clinical trial. Eur J Anaesthesiol. 2011 Jul;28(7):511-8. doi: 10.1097/EJA.0b013e32834515ba.

  PMID: 21455076 BACKGROUND

• Buckenmaier CC 3rd. Anaesthesia for outpatient knee surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):255-70. doi: 10.1053/bean.2002.0237.

  PMID: 12491556 BACKGROUND

• Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.

  PMID: 31980156 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sugantha Ganapathy, FRCPC

  London Health sciences Center, Western University, London, Ontario, Canada; N6A5A5

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CA (1)