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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Procare Riaya Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Procare Riaya Hospital
  • Procare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

GROUP 1 : G20

GROUP 2 : G25

GROUP 3 : G30

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physiotherapy tolerance
evaluated using VAS 10 points-scale were recorded : 0 - 3 = easy physiotherapy well tolerated rated as (1) , 4 - 6 = physiotherapy is tolerated with moderate pain rated as (2) and 7 - 10 = physiotherapy is painful and not tolerated rated as (3) .
Time to discharge
time to discharge is measured by days : starting on the day of surgery till the day of discharge home

Full Information

First Posted
June 12, 2016
Last Updated
August 11, 2018
Sponsor
Procare Riaya Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02805920
Brief Title
Comparison Between 3 Solutions of Bupivacaine of Adductor Canal Block for Anterior Cruciate Ligament Reconstruction
Official Title
Adductor Canal Block for Postoperative Analgesia After Anterior Cruciate Ligament Reconstruction: Comparison Between 3 Bupivacaine Volumes and Doses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Procare Riaya Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
After institutional review board approval and informed written consent, 90 males patients, elective unilateral arthroscopic anterior cruciate ligament reconstruction surgery under general anesthesia, The investigators enrolled adult male patients aged 18 to 50 yr, with American physical classification (ASA) I, II body mass index ≤ 35 kg/m2 and surgery lasting less than 2 h. Exclusion criteria were: 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. After arrival in the operating room, an 18-gauge intravenous in the upper limb catheter and ASA standard monitoring was placed. Standard intravenous premedication (3 mg of midazolam and 50 mcg of fentanyl) was given to all patients and supplemental oxygen was administered via facemask (5 L/min) throughout the block period. All Patients were randomly allocated to received an ultrasound-guided (GE Logic; GE, USA) ACB with 0.25% bupivacaine 1 of 3 solutions: group 1 (G20) 20 ml, group 2 (G25) 25 ml and group 3 (G30) 30 ml. ACB was performed in supine position at the mid-thigh level with leg slightly rotated externally. After skin sterilization, a 100-mm 21Gauge needle inserted in-plane through the sartorius muscle and fascia and next to the femoral artery into the adductor canal. Three anesthesia operators participated in the study: the first operator performs all US-guided needles insertion, the second operator perform the injection of the local solution. Blinding of the first operator was ensured as follow: (i) the first operator was unaware of volume-dose injected with his back toward to the second operator. (ii) the second operator using opaque syringes. The solution was injected in increment doses after negative aspiration to avoid intravascular injection. The blinded third operator performed the postblock assessment of sensory block and motor blockade flowing the block placement. All patients were evaluated for block success by checking pinprick and cold sensation in the saphenous distribution on the lower medial leg using a 25-gauge needle and a 3-point scale (0 = normal sensation, 1 = cold touch without pinprick, and 2 = absence of sensation). Successful blockade was defined as a change from normal sensation at baseline (0) to a score of 1 or 2. Sensation was tested at 15 and 30 minutes after nerve block and if block success was not achieved after 30 min, the operator consider the block as failure. Motor assessment was performed every 15 min up to 60 mn using a handheld isometric force electromechanical dynamometer (MicroFET2; Hoggan Health Industries Inc., USA) for quadriceps muscle power evaluation. Before the operation, all patients received instructions for using a 100-mm VAS score (with 0 = no pain, to 100 = the worst imaginable pain). Hereafter, all patients received standard general anesthesia and were induced with propofol (2.5 mg/kg), cisatracurium (0.2 mg/kg) and fentanyl (0.002 mg/kg) and maintained with nitrous oxide 50% in oxygen and sevoflurane. No other supplementary analgesic medication was given during the operation after the first dose of fentanyl. During anesthesia, controlled ventilation was performed via an endotracheal tube. Before surgical incision, a thigh pneumatic tourniquet on the same side as the surgery, at a pressure of 300 mm Hg, was applied to all patients. The same surgeon performed all surgical procedures using a standard surgical technique. After the end of anesthesia, patients were transferred to the post-anesthesia care unit (PACU). Arrival at PACU was recorded as time zero. The VAS was assessed at predetermined intervals after surgery (0, 15, 30, 45, 60, 90, 120 min) and following PACU discharge at 4, 6, 12, and 24 h. In PACU, when the VAS was greater than 4, IV morphine was titrated every 5min by 3mg. Pain was assessed every 5 min until pain relief, defined as a VAS ≤ 4. The modified Aldrete score were used to assure safe PACU discharge. Following PACU discharge, the first 24-h analgesia consisted of Pethidine 25 to 50 mg IV infusion repeated every 2 to 4 h as required. VAS score measurement in PACU and the first 24 postoperatively were assessed. PACU Morphine consumption and subsequent 24 -pethidine consumption were recorded. In addition, Time to discharge and the tolerance of physiotherapy as evaluated using VAS 10 points-scale were assessed : 0 - 3 = easy physiotherapy well tolerated rated as 1 , 4 - 6 = physiotherapy is tolerated with moderate pain rated as 2 and 7 - 10 = physiotherapy is painful and not tolerated rated as 3 . Systemic side effects of analgesia were also reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1 : G20
Arm Type
Active Comparator
Arm Description
Postoperative pain for ACLR : G20 : received ACB with 20 ml 0.25% Bupivacaine
Arm Title
GROUP 2 : G25
Arm Type
Active Comparator
Arm Description
Postoperative pain for ACLR : G25: received ACB with 25 ml 0.25% Bupivacaine
Arm Title
GROUP 3 : G30
Arm Type
Active Comparator
Arm Description
Postoperative pain for ACLR : G30 received ACB with 30 ml 0.25% Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
comparison of different volumes-dosages of 0.25% Bupivacaine
Primary Outcome Measure Information:
Title
postoperative pain
Description
assessment by the visual analog scale (VAS) pain scores. Analgesic consumption
Time Frame
24 days hours
Secondary Outcome Measure Information:
Title
Physiotherapy tolerance
Description
evaluated using VAS 10 points-scale were recorded : 0 - 3 = easy physiotherapy well tolerated rated as (1) , 4 - 6 = physiotherapy is tolerated with moderate pain rated as (2) and 7 - 10 = physiotherapy is painful and not tolerated rated as (3) .
Time Frame
3 days
Title
Time to discharge
Description
time to discharge is measured by days : starting on the day of surgery till the day of discharge home
Time Frame
3 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American ASA I, II body mass index ≤ 35 kg/m2 surgery time ≤ 2 hours Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHED ZEIDAN, MD
Organizational Affiliation
Procare Riaya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Procare Riaya Hospital
City
Khobar
State/Province
Eastern Province
ZIP/Postal Code
31952
Country
Saudi Arabia
Facility Name
Procare
City
Khobar
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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