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.: PACTR201704002183964 Date of Approval: 06/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined preincisional infiltration and intraperitoneal instillation of levobupivacaine - Tramal compared with levobupivacaine - ketamine for preempti
Official scientific title Combined preincisional infiltration and intraperitoneal instillation of levobupivacaine - Tramal compared with levobupivacaine - ketamine for preemptive analgesia after laparoscopic ovarian drilling. Useful or not?
Brief summary describing the background and objectives of the trial to evaluate the efficacy of combined preincisional local administration (at trocar incisional sites) and intraperitoneal instillation of levobupivacaine 0.25% with Tramadol compared with levobupivacaine with ketamine for preemptive analgesia after laparoscopic ovarian drilling.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) A prospective doubl
Disease(s) or condition(s) being studied Obstetrics and Gynecology,preemptive analgesia after laparoscopic ovarian drilling
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/04/2017
Actual trial start date 10/04/2017
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date 01/08/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Randomization was performed through a computer-generated, random-number list. The random number list was generated by means of the QuickCalcs (GraphPad Software Inc., La Jolla, CA, USA). The group assignment numbers were sealed in an envelope and kept by the study supervisor. After the written consent was signed, the opaque envelope was unsealed to determine which drug would be used. Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 - Levobupivacaine and Tramadol 30ml of 0.25% Levobupivacaine and 100mg Tramadol Once Preincisional infiltration and intraperitoneal instillation with Levobupivacaine and Tramadol 30
Experimental Group Group 2 - Levobupivacaine and Ketamine 30ml of 0.25% Levobupivacain and 0.5mg/kg Ketaine once Preincisional infiltration and intraperitoneal instillation with Levobupivacaine and Ketamine 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria were American Society of Anesthesiologists (ASA) physical status I-II and age between and age between 25 and 35 years, scheduled to undergo diagnostic laparoscopy and LOD under general anesthesia. Exclusion criteria were ASA physical status of more than II, known allergy to local anesthetic agents or narcotics, morbid obesity, history of a major psychiatric disorder, coagulation disorders, chronic pain syndrome, presence of uterine fibroid or adnexal pathology, history of pelvic operations or endometriosis, cardiac disease, renal failure, chronic opioids use, and current opioids treatment. Patients were informed with complete data about the techniques of analgesia and anesthesia. 25 Year(s) 35 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 14/01/2016 researsh Ethics Committe,Quality Assurance Unite
Ethics Committee Address
Street address City Postal code Country
tanta university hospital tanta 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures were visual analog scale pain scores and postoperative analgesic consumption. The primary outcome measurements of the current study included average postoperative VAS pain scores (for incisional, abdominal and shoulder pain) and postoperative analgesic consumption. Secondary outcome measurements were length of hospital stay, time to return to normal activities and overall patient satisfaction with analgesia.
Secondary Outcome Secondary outcome measurements were length of hospital stay, time to return to normal activities and overall patient satisfaction with analgesia. Secondary outcome measurements were length of hospital stay, time to return to normal activities and overall patient satisfaction with analgesia.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital algash street tanta 1234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital Egypt University
COLLABORATORS
Name Street address City Postal code Country
nagat sayed elshmaa tanta tanta 1234 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nagat elshmaa nagat_elshmaa@yahoo.com 01211865637 stat street
City Postal code Country Position/Affiliation
tanta 1234 Egypt professor in tanta university hospital
Role Name Email Phone Street address
Public Enquiries doaa elamrousy doaamoha@yahoo.com 01278155283 algaish street
City Postal code Country Position/Affiliation
tanta 1234 Egypt professor in tanta university hospital
Role Name Email Phone Street address
Scientific Enquiries doaa elamrousy doaamoha@yahoo.com 01278155283 algaish street
City Postal code Country Position/Affiliation
tanta 1234 Egypt professor in tanta university hospital
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information