CTRI Number |
CTRI/2016/08/007200 [Registered on: 17/08/2016] Trial Registered Prospectively |
Last Modified On: |
17/08/2016 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Prolonged postoperative surgical pain after laparoscopic cholecystectomy |
Scientific Title of Study
|
Incidence of chronic postoperative surgical pain after laparoscopic cholecystectomy:A comparison between dexmedetomidine- fentanyl and propofol-fentanyl based total intravenous anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
K Himabindu |
Designation |
Post-graduation (MD), Anaesthesiology |
Affiliation |
Sri Venkateswara Institute of Medical Sciences |
Address |
Dr. Aloka Samantaray
Additional professor
Department of Anaesthesiology& Critical Care
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor ANDHRA PRADESH 517507 India |
Phone |
9490713247 |
Fax |
|
Email |
himabindukotamarthy@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr K Himabindu |
Designation |
PG student |
Affiliation |
Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati |
Address |
Department of Anaesthesiology& Critical Care
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor ANDHRA PRADESH 517507 India |
Phone |
|
Fax |
|
Email |
himabindukotamarthy@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Aloka Samantaray |
Designation |
Additional professor |
Affiliation |
Department of Anaesthesiology& Critical Care Sri Venkateswara Institute of Medical Sciences Tirupati |
Address |
Department of Anaesthesiology& Critical Care
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor ANDHRA PRADESH 517507 India |
Phone |
|
Fax |
|
Email |
aloksvims@gmail.com |
|
Source of Monetary or Material Support
|
Sri Venkateswara institute of Medical Sciences |
|
Primary Sponsor
|
Name |
DirectorSri Venkateswara Institute of Medical Sciences |
Address |
Department of Anaesthesiology& Critical Care
Sri Venkateswara Institute of Medical Sciences
Tirupati.517507
|
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Aloka Samantaray |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology & Critical Care
Chittoor ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Inclusion criteria:
Scheduled for elective laparoscopic cholecystectomy
Patients aged 18-60 years
American Society of Anesthesiologists Physical Status I & II
, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Dexmedetomidine-fentanyl froup |
Induction with injection dexmedetomidine 1mcg/kg slowIV over 10 minutes and maintenance with 0.3-1mcg/kg dexmedetomidine along with fentanyl infusion at rate of 1mcg/kg/hr. |
Intervention |
Propofol-fentanyl group |
Induction with injection propofol 1.5mg/kg IV and maintenance with 3-12mg/kg/h propofol infusion along with fentanyl infusion at rate of 1mcg/kg/hr. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Day(s) |
Gender |
Both |
Details |
Inclusion criteria:
Scheduled for elective laparoscopic cholecystectomy
Ppatients aged 18-60 years
American Society of Anesthesiologists Physical Status I & II15
|
|
ExclusionCriteria |
Details |
Exclusion criteria:
Chronic opioid users
Pre-existing pain syndrome
Severe cardiovascular(New York Heart Association class III or IV)
Severe pulmonary and renal disease
Inability to communicate and understand Pain scale(Visual analogue scale)
Pregnant and lactating mothers
Patients not willing to participate in the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Primary objective is to find out the incidence of chronic post-operative surgical pain(CPSP) after laparoscopic cholecystectomy |
At 1st,2nd,3rd and 4th months after surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
2. Secondary objective is to compare the
(1)incidence of CPSP and (2)recovery profile between two different types of TIVA. |
(1)1st ,2nd ,3 rd and 4th month after laparoscopic cholecystectomy
(2)Post operative period (time frame 0-24h) |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
19/09/2016 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Persistence of pain is less common after laparoscopic cholecystectomy(LC) than open cholecystectomy(OC).Incidence of persistent pain symptoms after LC is 13%. where as incidence of chronic post operative surgical pain (CPSP) after OC cholecystectomy is around 3-51%4. Laparoscopic cholecystectomy being carried out as a day care procedure but very little is known about the actual incidence of CPSP after this procedure.Total intravenous anaesthesia (TIVA) is better compared to general anaesthesia in terms of better hemodynamic stability, recovery profile and lesser incidence of post-operative nausea and vomiting and therefore considered as a better technique in day care surgeries.Propofol (2, 6-disopropylphenol) is a short-acting intravenous anaesthetic agent that is widely used for total intravenous anaesthesia (TIVA) to induce and maintain anaesthesia, as well as for sedation.Dexmedetomidine is an alpha-2 agonist having both sedative and analgesic property. Intravenous (IV) dexmedetomidine is effective as a primary sedative in adult patients undergoing a variety of diagnostic or surgical procedures requiring monitored anaesthesia care.Furthermore there are no Indian data available at present to describe about the effect of type of anaesthesia on CPSP after laparoscopic cholecystectomy.We therefore would like to compare the incidence of CPSP after two different types of TIVA.The Primary objective is to find out the incidence of chronic post-operative surgical pain(CPSP) after laparoscopic cholecystectomy and the secondary objective is to compare the incidence of CPSP and recovery profile between two different types of TIVA. Patients will be randomised to receive either either fentanyl-propofol or fentanyl-dexmedetomidine to maintain Bispectral index around 40-50 and or to maintain hemodynamic variables within 20% of baseline after standard anaesthesia induction as per group allocation. All patients will be operated by the same surgical team with the standard number of port placement and surgical steps. All patients will receive injection ondansetron 0.1mg/kg IV and injection paracetamol 1g IV after deflation of gas. Infusion of study drug stopped before closure of last laparoscopic port. All the port sites will receive infiltration with 0.5% bupivacaine 5ml diluted to 10ml with normal saline. At the end of surgery residual neuromuscular blockade will be reversed with injection neostigmine 0.05-0.07mg/kg and injection glycopyrrolate 20mcg/kg IV.Time from administration of reversal agent to time to eye opening, time to achieve limb lift on command will be noted. After satisfying extubation criteria patient will be extubated and shifted to post anaesthesia care unit (PACU). Modified Aldrete score will be assessed every hourly until score>9 and it will be noted. A fixed post-operative analgesic regimen will be standardized in the PACU. Pain will be assessed by NRS every 30 minutes and injection tramadol 100mg bolus IV will be administered on patients demand or when the NRS > 3 at rest in the postoperative period. This will be followed by injection tramadol 50mg IV every 8th hourly. All patients will be visited 24 hrs post op in respective wards & will be asked about presence of nausea, vomiting& pain in non-leading manner. If the patient complains of pain injection fentanyl 1mcg/kg will be given IV followed by 0.5mcg/kg IV after 20 minutes till NRS<3 at rest and NRS<4 during cough. The number of rescue analgesics,total amount of fentanyl consumption and maximum pain score by NRS will be noted. Before discharge from the hospital patients will be informed of the long term pain they might continue to experience at the end of two and four months. Each patient will be interviewed over telephone by an investigator at 1st, 2nd, 3rd, 4th month after the surgery. Patients will be asked questions about pain intensity at daily life activity, location of the pain, characteristics of the pain[allodynia-like pain (pain owing to a stimulus that does not normally provoke pain; such as gentle touching of the skin by hand or clothing), burningpain, pain in response to cold, lacerating pain, a ‘pins and needles’ sensation, and aches.],duration of the pain and use of analgesic drugs. If pain is present at the time of interview, the patient will be asked to rate the intensity of the pain during the most recent 7 days at daily life activity using an NRS. |