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.: PACTR201808753623924 Date of Approval: 28/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative evaluation of intraperitoneal bupivacaine and bupivacaine ketamine combined with lung recruitment for reducing postoperative shoulder pain in laparoscopic cholecystectomy
Official scientific title Comparative evaluation of intraperitoneal bupivacaine and bupivacaine ketamine combined with lung recruitment for reducing postoperative shoulder pain in laparoscopic cholecystectomy
Brief summary describing the background and objectives of the trial Shoulder pain (SP) was first reported after laparoscopic gynecological procedures. It is assumed to be multifactorial in nature. Several methods to reduce SP after laparoscopic cholecystectomy (LC) have been postulated. In this study, we have worked to decrease it using 2 approaches; lung recruitment maneuver and intraperitoneal local analgesic instillation. This study is designed to assess the clinical efficacy of ketamine as an adjunct to intraperitoneal bupivacaine for the relief of post-operative shoulder pain after LC
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: Drugs
Anticipated trial start date 15/09/2018
Actual trial start date 15/09/2018
Anticipated date of last follow up 17/11/2018
Actual Last follow-up date 17/11/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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 randomization using a randomization table created by a computer software program 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
Control Group Group 1 or Bupivacaine group or B group 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution. At the start of surgery and just after inflating the pneumoperitoneum and before any dissection, the surgeon sprayed 50 mL of a blinded solution At the start of surgery and just after inflating the pneumoperitoneum and before any dissection, the surgeon sprayed 50 mL of bupivacaine intraperitoneally in a standardized manner to the subdiaphragmatic space and gallbladder area guided by the camera and the patients were kept in Trendelenburg position for 5-10 minutes 20 Placebo
Experimental Group Group 2 or Bupivacaine Ketamine Group or BK group 0.5 mg/kg ketamine mixed with bupivacaine 0.25% with a total volume of 50 ml intraperitoneal instilled solution. At the start of surgery and just after inflating the pneumoperitoneum and before any dissection, the surgeon sprayed 50 mL of bupivacaine ketamine At the start of surgery and just after inflating the pneumoperitoneum and before any dissection, the surgeon sprayed 50 mL of bupivacaine ketamine intraperitoneally in a standardized manner to the subdiaphragmatic space and gallbladder area guided by the camera and the patients were kept in Trendelenburg position for 5-10 minutes. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Either sex, American Society of Anesthesiologists (ASA) I-II, With age range of 20 to 50 years, Body weight from 70-80 kg, Planned for elective laparoscopic cholecystectomy Patients with chronic pain diseases other than gallstone disease, Opioids users Patients known to have amide local anesthetic allergy Patients with acute cholecystitis Conversion to an open cholecystectomy Postoperative complications that increased postoperative pain Those with psychological or nervous system diseases Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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
Yes 14/08/2018 Faculty of medicine Research Ethical Committee FWA 000017585 FMASU
Ethics Committee Address
Street address City Postal code Country
Abbasseya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome was the intensity of post-laparoscopic pain in shoulder at 24 h after surgery At the 24th hour postoperatively
Secondary Outcome abdominal pain intensity, postoperative amount of analgesics, nausea, and vomiting and sedation level Once reaching the recovery room, and at 1, 2, 6, 12, and 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Sham University El Demerdash hospitals Abbaseyya Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Abbasseya Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raham Hasan Mostafa rahamhasan@yahoo.com +0201222530020 Ibn Hanbal Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturers of Anesthesia Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Yehia Mamdouh Hassan Mekki yehiamamdouh81@gmail.com +0201006543180 34 Mohammed Fahmy El-Mohdar
City Postal code Country Position/Affiliation
Cairo 11111 Egypt Lecturer of Anesthesia Ain Shams university
Role Name Email Phone Street address
Public Enquiries Raham Hasan Mostafa rahamhasan@yahoo.com +0201222530020 Ibn Hanbal Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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