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.: PACTR201903770607799 Date of Approval: 08/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic effect of acupucture
Official scientific title Post-Operative Analgesic Effect Of Electric Ear Acupuncture In Patients Undergoing Abdominal Hysterectomy In Suez Canal University Hospital, A Randomized Controlled Study.
Brief summary describing the background and objectives of the trial Acupuncture is considered as a traditional therapeutic technique with a long history of 4000 years. electroacupuncture (EA) is a modern version of hand acupuncture can provide a valid analgesia with a little physiological interference.Systematic reviews showed that acupuncture is a useful adjuvant for management of post-operative pain. Randomised controlled trials have found that acupuncture can ameliorate post-operative pain, reduce the use of patient-controlled analgesia (opioids), and post-operative nausea and vomiting.Our Primary objective is to Evaluate the effect of auricular acupuncture on postoperative analgesic requirement in the first 24 hours .Secondary objectives include Evaluation of the effect of auricular acupuncture on Intraoperative hemodynamic parameters,Post-operative pain by using Visual analog scale (VAS) pain score where VAS1-4 (mild pain).VAS 5-6 (moderate pain).VAS more than 6 (severe pain). and Postoperative 1st request of analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/03/2019
Actual trial start date
Anticipated date of last follow up 10/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status Completed
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group 1-spinal anaesthesia with hyperbaric bupivacaine 0.5% (15-20 mg) 2- Diclofenac potassium 75 mg once after hemodynamic monitoring,An 18- gauge intravenous cannula will be inserted into the patient's forearm and 500 mills of intravenous fluid (ringer acetate) will be administrated. premedications will not be given. All patients in both groups will be given spinal anaesthesia by 25 G needle with hyperbaric bupivacaine 0.5% (15-20 mg) according to the patient’s height, in the L 4- L 5 intervertebral space. During spinal injection, no supplementary opioids will be given; the level of anaesthesia will be assessed by pin-prick every five minutes in the first 20 minutes till it reached T4-T6 level which considered sufficient to start surgery.When the reported VAS score is 3 or more, a loading dose of 5 mg morphine will be administered via slow i.v route. Then, a PCA will be administered. The PCA pump will be loaded with 1mg / ml of morphine and set to deliver on demand doses of 2 ml with 5 minutes lockout intervals. Background infusion will not be allowed. At the End of operation Diclofenac potassium 75 mg will be administered to all patients by intramuscular injection. 28 Active-Treatment of Control Group
Experimental Group electrical ear acupuncture group 1-spinal anaesthesia with hyperbaric bupivacaine 0.5% (15-20 mg) 2-electric ear acupuncture throughout surgery 3-press needles in the ear to be removed after 24 hours 4- Diclofenac potassium 75 mg once after hemodynamic monitoring,An 18- gauge intravenous cannula will be inserted into the patient's forearm and 500 mills of intravenous fluid (ringer acetate) will be administrated. premedications will not be given. All patients in both groups will be given spinal anaesthesia by 25 G needle with hyperbaric bupivacaine 0.5% (15-20 mg) according to the patient’s height, in the L 4- L 5 intervertebral space. During spinal injection, no supplementary opioids will be given; the level of anaesthesia will be assessed by pin-prick every five minutes in the first 20 minutes till it reached T4-T6 level which considered sufficient to start surgery.. Electric ear acupuncture will be done by fine needles (10mm x 30guage) to the anatomically defined 4 points of ear acupuncture which are called ; Shen Men Point (Divine Gate Point ) or point 55 which is a sedative analgesic anti-inflammatory point, thalamus Point - 26 which is an analgesic point in acute and chronic severe pain , Analgesia Point 3, and Uterus Point __ 58.Then four pre-sterilized single use acupuncture needles will inserted in the predetermined acupoints and connected to clamps of electrode cords that are connected to electro-acupuncture therapeutic apparatus (KWD-808I MULTIPURPOSE HEALTH DEVICE, ChangzhouYingdi Electronic Medical Device Co., China.The electro-acupuncture device will be switched on and adjusted according to instruction manual for use to provide continuous wave with a frequency of 2Hz and output impulse amplitude of 6-10 volts according to patient's ability. At the end of surgery, the electro-acupuncture device will be switched off and the fine needles will be replaced by press needles in the same acupoints to be removed after 24 hours. When the reported VAS score is 3 or more, a loading dose of 5 mg morphine will be administered via slow i.v route. Then, a PCA will be administered. The PCA pump will be loaded with 1mg / ml of morphine and set to deliver on demand doses of 2 ml with 5 minutes lockout intervals. Background infusion will not be allowed At the End of operation . Diclofenac potassium 75 mg will be administered to all patients by intramuscular injection. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age between 21-60 years old scheduled for elective abdominal hysterectomy. 2- American society of anaesthesiologist (ASA) physical status I & II 1-Contraindications of spinal anaesthesia or auricular acupuncture as (infection at the site of puncture, coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs). 2- Patients known to have allergy or sensitivity to morphine, and / or bupivacaine. 3-Morbid obesity (body mass index (BMI)> 35 Kg/m2). 4- Psychological disease. 5-Narcotic abuse, Prolonged use of sedatives or opioid drug use . 6-Contraindications for Ear acupuncture (infection at the acupuncture site ) . 7-Patient refusal to participate in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 60 Year(s) Female
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
Yes 27/01/2019 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
kilo 4.5 ring road ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative analgesic requirement the first 24 hours
Secondary Outcome blood pressure, heart rate, respiratory rate and oxygen saturation every 5 minutes in the first 20 minutes, then every 20 minutes for the rest of surgery
Secondary Outcome Post-operative pain assessed by Visual analog scale after 30 minutes, 1, 3, 6, 12 and 24 h
Secondary Outcome time to the 1st postoperative request of analgesia post operative
Secondary Outcome Side effects associated with morphine consumption as nausea, vomiting and over sedation will be recorded postopeerative immediately after discharge and after 30 minutes, 1, 3, 6, 12 and 24 h
Secondary Outcome duration of surgery and spinal level at the end of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital kilo 4.5,ring road ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hamdy hendawy elghaba street ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university kilo 4.5 ring road ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
hamdy ali hendawy elghaba street ismailia 41522 Egypt
mohamed elsayed abuelnaga ard elgameiat elshikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hamdy hendawy hamdy.hendawy@med.suez.edu.eg 00201143667734 elghaba street
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anaesthesia intensive care and pain management faculty of medicine suez canal university
Role Name Email Phone Street address
Scientific Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 00201004150671 ard elgameiat elshikh zayed
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anaesthesia intensive care and pain management faculty of medicine suez canal university
Role Name Email Phone Street address
Public Enquiries hamdy hendawy hamdy.hendawy@med.suez.edu.eg 00201143667734 elghaba street
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anaesthesia intensive care and pain management faculty of medicine suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article,after de identification (text ,tables ,figures,and appendices ) Informed Consent Form,Statistical Analysis Plan 10 months after trial completion to achieve aims and objectives of the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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