Comparison Between 3 Solutions of Bupivacaine of Adductor Canal Block for Anterior Cruciate Ligament Reconstruction

NCT02805920 | Completed DMC

• 1 other identifier: PRH10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with the FNB. This will serve as potential gain for early rehabilitation and thereby functional outcome. Adequate direct injection of local anesthetic into the canal will block four nerves: the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous nerve, and the terminal end of the posterior division of the obturator nerve. Anterior cruciate ligament reconstruction (ACLR) is often associated with postoperative severe pain. Postoperative early rehabilitation is the primary focus to restore pre-injury status and is an essential part of the full recovery, especially that this rehabilitation extents over a 6 month period. Early elimination of pain is necessary to achieve this goal. However, there are no clear conclusive clinical reports defining the adequate analgesic volume-dosage of local anesthetic for ACB for postoperative ACL pain management. The investigators speculated that volume-dosage manipulation play key role in the effective of ACB for postoperative pain. The investigators conducted this prospective, randomized, observer-blinded trial to compare 3 combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The first aim of the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine of the 3 doses as assessed by the visual analog scale (VAS) pain scores. The second aim were duration of analgesia, as defined by first demand for analgesia, and subsequent 24-h consumption. Physiotherapy tolerance and time to discharge were evaluated. Side effects were also assessed.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  assessment by the visual analog scale (VAS) pain scores. Analgesic consumption

  24 days hours

Secondary Outcomes (2)

• Physiotherapy tolerance

  3 days

• Time to discharge

  3 days

Study Arms (3)

GROUP 1 : G20

ACTIVE COMPARATOR

Postoperative pain for ACLR : G20 : received ACB with 20 ml 0.25% Bupivacaine

Drug: Bupivacaine

GROUP 2 : G25

ACTIVE COMPARATOR

Postoperative pain for ACLR : G25: received ACB with 25 ml 0.25% Bupivacaine

Drug: Bupivacaine

GROUP 3 : G30

ACTIVE COMPARATOR

Postoperative pain for ACLR : G30 received ACB with 30 ml 0.25% Bupivacaine

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

comparison of different volumes-dosages of 0.25% Bupivacaine

Also known as: Marcaine

GROUP 1 : G20; GROUP 2 : G25; GROUP 3 : G30

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American ASA I, II
• body mass index ≤ 35 kg/m2
• surgery time ≤ 2 hours

You may not qualify if:

• Infection at the side at the procedure site,
• Patients with diabetes mellitus,
• Intake of any analgesic during the last 48h,
• History to local anesthetics allergy

Sponsors & Collaborators

• Procare Riaya Hospital: lead

Study Sites (2)

Procare Riaya Hospital

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Procare

Khobar, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

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

• AHED ZEIDAN, MD

  Procare Riaya Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, MD, Consultant Anesthesia, Chair

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 20, 2016
• Study Start: August 30, 2016
• Primary Completion: April 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)