Protocol summary

Summary
Objective: Evaluation of Genicular Nerve Block for Postoperative Pain Management of Anterior Cruciate Ligament Reconstruction Surgery. Study design: a single blind randomized clinical trial Inclusion criteria: Patients aged 16-70 years with ASA 3-1 who suffer from anterior cruciate ligament (ACL) injury and who are candidates for rehabilitation and repair of the anterior cruciate ligament and have the ability to collaborate and answer to the study questions. Exclusion criteria : Patients with femoral and sciatica neuropathy; coagulopathy; infection in the blockade side ; Pregnancy; Chronic use of opium over 3 months; contraindication for regional anesthesia; allergy to the used drugs; renal or hepatic failure; uncontrolled epilepsy; contraindication for general anesthesia; severe anxiety and depression. Intervention: 50 patients will be randomly assigned to the one of the two groups of (B) or (S). local block procedure will have performed after induction of anesthesia and before surgery. Three genicular nerves: medial superior genicular nerves , medial inferior genicular nerve, lateral superior genicular nerves are diagnosed by the ultrasound sonography device , by using the Spinal needle gauge 22 patients’ knee will be blocked with 5 ml of Marcaine 0.5% added to 25 macro gram -epinephrine in group B while, 5 cc normal saline will be injected in the patients’ knee (in the control group = group S ). The severity of the pain in the recovery room will be evaluated every 15 minutes by the NRS. The time of the first demand for postoperative analgesics and total morphine consumption will be recorded. In the ward, an PCA pump will used with 0.5 mg / ml of morphine. Patient's pain in the first 24 hours after surgery will be measured at 2, 4, 6, 8, 12, 16, 20, and 24 with the NRS(Numerical Rating Scale). In case of NRS above 4 despite the use of PCA pump, pain will controlled based on the provided protocol in the recovery room . total morphine consumption will be recorded within the first 24 hours after the operation. Morphine-induced complications such as itching, nausea and vomiting, urinary retention, respiratory depression and sleepiness (based on the Wilson criteria) will be recorded at 4, 8, 12, 16, 20 and 24 hours after the operation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081619470N38
Registration date: 2017-08-23, 1396/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-23, 1396/06/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Shiraz University of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Genicular Nerve Block for Postoperative Pain Management of Anterior Cruciate Ligament Reconstruction Surgery.
Public title
Evaluation of Genicular Nerve Block for Postoperative Pain Management of Anterior Cruciate Ligament Reconstruction Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 16-70 years with ASA 3-1 who suffer from anterior cruciate ligament (ACL) injury and who are candidates for rehabilitation and repair of the anterior cruciate ligament and have the ability to collaborate and answer to the study questions. Exclusion criteria : Patients with femoral and sciatica neuropathy; coagulopathy; infection in the blockade side ; Pregnancy; Chronic use of opium over 3 months; contraindication for regional anesthesia; allergy to the used drugs; renal or hepatic failure; uncontrolled epilepsy; contraindication for general anesthesia; severe anxiety and depression.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-08-19, 1395/05/29
Ethics committee reference number
IR.SUMS.MED.REC.1395.09

Health conditions studied

1

Description of health condition studied
anterior cruciate ligament injury
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee

Primary outcomes

1

Description
Pain score
Timepoint
24 hours after surgery at 2, 4, 6, 8, 12, 16, 20, and 24
Method of measurement
Numerical rating scale (NRS)

Secondary outcomes

1

Description
Morphine-induced complications
Timepoint
at 4, 8, 12, 16, 20 and 24 hours after the operation
Method of measurement
observasion

Intervention groups

1

Description
Three genicular nerves: medial superior genicular nerves , medial inferior genicular nerve, lateral superior genicular nerves are diagnosed by the ultrasound sonography device , by using the Spinal needle gauge 22 patients’ knee will be blocked with 5 ml of Marcaine 0.5% added to 25 macro gram -epinephrine in group B
Category
Treatment - Drugs

2

Description
5 cc normal saline will be injected in the patients’ knee
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Hedye Moghaddasi
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hedye Moghadasi
Position
Anesthesiology resident/physician
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
hedyemoghaddasi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Seyed Hedayatollah Akhlagh
Position
Anesthesiologist/Pain Felloship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
akhlaghh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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