Prolonged postoperative surgical pain after laparoscopic cholecystectomy
- Conditions
- Inclusion criteria:Scheduled for elective laparoscopic cholecystectomyPatients aged 18-60 yearsAmerican Society of Anesthesiologists Physical Status I & II
- Registration Number
- CTRI/2016/08/007200
- Lead Sponsor
- DirectorSri Venkateswara Institute of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion criteria: Scheduled for elective laparoscopic cholecystectomy Ppatients aged 18-60 years American Society of Anesthesiologists Physical Status I & II15.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 2.Secondary objective is to compare the (1)incidence of CPSP and (2)recovery profile between two different types of TIVA.
Trial Locations
- Locations (1)
Sri Venkateswara Institute of Medical Sciences
🇮🇳Chittoor, ANDHRA PRADESH, India
Sri Venkateswara Institute of Medical Sciences🇮🇳Chittoor, ANDHRA PRADESH, IndiaDr Aloka SamantarayPrincipal investigator9493547653aloksvims@gmail.com