MedPath

Pain relief after laparoscopic procedure

Phase 1
Recruiting
Conditions
Calculus of gallbladder without cholecystitis,
Registration Number
CTRI/2018/05/013557
Lead Sponsor
Govt Medical College Amritsar
Brief Summary

The aim of the presentstudy is to compare and evaluate the effects of intraperitoneal instillation of0.25% levobupivacaine plus dexmedetomidine versus 0.25% ropivacaine plusdexmedetomidine for postoperative analgesia in patients undergoing laparoscopiccholecystectomy. The aim will be accomplished by carrying out a study on 90patients randomly divided into 3 groups of 30 each in the age group of 18-65years, of either sex, of ASA grade I, II and III selected for laparoscopiccholecystectomy after proper preanaesthetic check up. Postoperative analgesiawill be achieved in group L by using 40 ml of 0.25% levobupivacaine plusdexmedetomidine @ 1µgm per Kg Body weight and in group R by using 40 ml of0.25% ropivacaine plus dexmedetomidine @ 1µgm per Kg Body weight and Group Cwill be given 40 ml Normal Saline.  Thethree groups will be compared with respect to haemodynamic changes, onset andregression of analgesia, requirement of rescue analgesia, side effects andcomplications with the help of scale discussed in plan. The observation will berecorded and the results will be statistically analysed.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
60
Inclusion Criteria
    1. All patients of 18.
  • 65 years of either sex 2. All ASA grade I and II admitted in the Surgery department. 3. Patients posted for laparoscopic cholecystectomy surgery under general anaesthesia.
Exclusion Criteria
  • Pregnant and lactating women Patients with morbid obesity i.e. BMI of 35 Kg/m2.
  • Patients on psychotropic or adrenergic drugs Refusal by patient to enlist in study â—Patients with chronic pain syndrome.
  • â—History of previous abdominal surgery.
  • Allergy to study drug.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To study the post-operative analgesic effect of 0.25% levobupivacaine plus dexmedetomidine with 0.25% ropivacaine plus dexmedetomidine with Normal Saline (Control Group) following intra-peritoneal instillation in laparoscopic cholecystectomy.8 hours
2.Duration of postoperative analgesia (hours).8 hours
3.To assess the need of rescue analgesics in post-operative period in all the groups.8 hours
Secondary Outcome Measures
NameTimeMethod
1.Haemodynamic changes.2.Any side effects or complications (confusion, dizziness, auditory and visual disturbances, convulsions, hypertension and cardiovascular collapse, tachycardia, arrthymias and respiratory depression).

Trial Locations

Locations (1)

Govt Medical College Amritsar

🇮🇳

Amritsar, PUNJAB, India

Govt Medical College Amritsar
🇮🇳Amritsar, PUNJAB, India
Dr Joginder Pal
Principal investigator
9501025275
jpattri12@yahoo.co.in

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