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.: PACTR201604001577314 Date of Approval: 10/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexamethasone versus Dexmedetomidine as Local Anesthetic Adjuvants in Ultrasound Guided Transversus Abdominis Plane Block for Total Abdominal Hysterectomies
Official scientific title Dexamethasone versus Dexmedetomidine as Local Anesthetic Adjuvants in Ultrasound Guided Transversus Abdominis Plane Block for Total Abdominal Hysterectomies
Brief summary describing the background and objectives of the trial The transversus abdominis plane (TAP) block is most often used to provide surgical anesthesia for minor, superficial procedures on the lower abdominal wall, or postoperative analgesia for procedures below the umbilicus providing anesthesia to the ipsilateral lower abdomen below the umbilicus. The TAP block was shown to reduce the need for postoperative opioid use, increase the time to first request for further analgesia, and provide more effective pain relief, while decreasing opioid related side effects such as sedation and postoperative nausea and vomiting. The provision of effective postoperative analgesia is of key importance to facilitate early ambulation and prevention of postoperative morbidity. The analgesic regimen needs to meet the goals of providing safe, effective analgesia, with minimal side effects. Many additives to local anesthetics used to prolong the duration of analgesia for peripheral nerve blocks have been studied which include epinephrine, clonidine, buprenorphine, tramadol, sodium bicarbonate, midazolam, dexamethasone, dexmedetomidine, Fentanyl, ketamine and neostigmine.The objective is to compare efficacy and safety of dexmedetomidine and dexamethasone as local anesthetic adjuvant in TAP block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 31/12/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
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 computer generated random numbers Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamethasone with bupivacain in TAPB 8 mg once after induction of anesthesia Local anesthetic adjuvant 27
Experimental Group Dexmedetomidine with bupivacaine in TAPB 0.8 mic/kg once after induction of anesthesia adjuvant to local anesthestic 27
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing an abdominal hysterectomy. ASA I and II physical status. Patient refusal. Body mass index (BMI) > 40. Patients with chronic pain. Those using chronic analgesic medications. Coagulopathy. Allergy to the study drugs. Patients taking other medications with ¿-adrenergic blocking effect. Hepatic or renal insufficiency. Systemic infection. Infection at the site of injection. 25 Year(s) 55 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 02/03/2015 Research ethical committee - Faculty of medicine - Fayoum University
Ethics Committee Address
Street address City Postal code Country
Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain by visual analog scale (VAS) 2 hour. 4 hour. 6 hour. 12 hour. 18 hour. 24 hour. 48 hour postoperatively
Secondary Outcome intraoperative fentanyl consumption Once
Secondary Outcome Time to first analgesia (TFA) after operation Once
Secondary Outcome Total morphine dose consumption in 24h postoperatively 2 hour. 4 hour. 6 hour. 12 hour. 18 hour. 24 hour. 48 hour postoperatively
Secondary Outcome Occurrence of postoperative nausea and vomiting Once
Secondary Outcome Assessment of alertness / sedation scale according to a five-point scale Once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hany Mahmoud Yassin Moussa 303t, Hadaek Al-Ahram, Giza Giza 12572 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Yassin hmy00@fayoum.edu.eg 00201111363602 303t, Hadaek Al-Ahram
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Public Enquiries Yasser Salim yasser.salem@yahoo.com 00201009314178 Sheikh Amer st.
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Assisstant lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Mahdy Abd Elhady mahdyanesthesia@yahoo.com 00201024606006 Sheikh Amer st.
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Assisstant lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
REPORTING
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