Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002261398 Date of Approval: 04/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Acupuncture on the Management of Postoperative pain control in total knee arthroplasty.
Official scientific title The Effect of Acupuncture on the Management of Postoperative pain control in total knee arthroplasty.
Brief summary describing the background and objectives of the trial Total knee arthroplasty (TKA) is a painful procedure. Even with patient-controlled intravenous opioids and nonsteroidal antiinflammatory drugs, pain can persist, especially during mobilization. Recently Electroacupuncture (EA) has been used to relieve postoperative pain after TKA with positive results (Tzeng CY, Acupuncture in medicine, 2015). The aim of the study is to compare in a prospective randomized double-blinded trial the EA + adductor canal block (ACB) to ACB alone over analgesic requirement in TKA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post operative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Electroacupuncture plus adductor canal block
Anticipated trial start date 01/06/2017
Actual trial start date
Anticipated date of last follow up 03/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Electroacupuncture with continuous adductor canal block. 2 sessions of acupuncture with 9 acupoints during 30 minutes each session and 0.2 % ropivacaïne administered continuously into the adductor canal catheter. 2 days. At each session, nine needles will be inserted for each patient (SI4 and LI 11 in the upper limbs, E34, E36, GB34, SP 6 and LV3 contralateral to the operative leg.) 44
Control Group Sham acupuncture with continuous adductor canal block. 2 sessions of sham acupuncture with 9 needles during 30 minutes each session and 0.2 % ropivacaïne administered continuously into the adductor canal catheter. 2 days. 9 needles will be inserted in non-specific acupoints during 30 minutes. 44 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for primary total knee arthroplasty under spinal anesthesia. ¿ Contraindication to EA (severe cardiac arrhythmia, seizure disorder, history of psychiatric disease or drug abuse.) ¿ Acupuncture treatment within 1 month before the trial. ¿ Refusal of acupuncture. ¿ Difficulty of communication (deaf patients, demented patients, patients with psychological disorders¿) ¿ Contraindication to antiinflammatory drug (patients with ulcer or gastritis, renal failure¿) ¿ Allergy to any of the study medications. ¿ Contraindication to the realization of spinal anesthesia or refusal of spinal anesthesia. 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 23/05/2017 CE-IMKO
Ethics Committee Address
Street address City Postal code Country
avenue Habib Bourguiba Ksar said manouba 2010 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the morphine consumption during the first 48 hours. 2, 4, 6, 8, 12, 24, 36, 48 post operative hours.
Secondary Outcome The time to the first PCA request. 3 first postoperative hours.
Secondary Outcome Numerical rating scale pain scores. 2, 4, 6, 8, 12, 24, 36, 48 postoperative hours.
Secondary Outcome Mobilization ability. at 24 and 48 h post surgery.
Secondary Outcome The incidence of analgesia-related adverse effects. 48 hours postoperatively.
Secondary Outcome Length of hospital stay (days). 1 week.
Secondary Outcome Chronic pain. at 3 and 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kassab orthopedic institute. Avenue Habib Bourguiba KSAR SAÏD. Manouba 2010 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Kassab orthopedic institute Avenue Habib Bourguiba Ksar Said Manouba 2010 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kassab orthopedic institute Avenue Habib Bourguiba Ksar Said Manouba 2010 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Radhouani Avenue Habib Bourguiba Ksar Said Manouba 2010 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faten Haddad faten.haddad@hotmail.fr 0021626209158 Avenue Habib Bourguiba Ksar Said.
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia Junior anesthesiologist
Role Name Email Phone Street address
Public Enquiries Olfa Kaabachi olfa.kaabachi@gnet.tn 0021698317381 Avenue Habib Bourguiba Ksar Said.
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia Head of the department of anesthesiology and intensive care.
Role Name Email Phone Street address
Scientific Enquiries Kheireddine Raddaoui khairirad@yahoo.fr 0021653066561 Avenue Habib Bourguiba Ksar Said.
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia Senior anesthesiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information