Post-operative Pain
Conditions
Brief summary
To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.
Interventions
DRUGBupivacaine
1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
DRUG0.9% normal saline
1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU * Patients who are eligible according to ASA Ⅰ -Ⅱ * Female or male, age ≥18 years * Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy * Discharge of patient between 12 hour to 36 hour after performing procedure * Patients given consent for enrollment in study
Exclusion criteria
* Patients known to be allergic to certain recommended drugs * If patients have history of psychiatric illness * Patients on chronic analgesic therapy for any other indication * Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy * Duration of surgery more than 1 hour * Patients undergoing laparoscopic cholecystectomy for complex gallbladder disease such as incidental gallbladder pancreatitis, gallstone pancreatitis, cholecystoduodenal fistula, mirizzi syndrome * Special population group such as children, pregnant woman, patients with cirrhosis, diabetics * Duration of operative procedure more than 1 hour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain: VAS | 12 hours | Post-operative pain in visual analog scale ranging 0 to100 |
| Post-operative pain: rating scale | 12 HOURS | Post-operative pain in numerical rating scale ranging 0 to 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during hospital discharge: VAS | 3-5days | visual analog scale score during hospital discharge rangibg 0-100 |
| Patient Satisfaction Level: questionnaire | 24 hour | Patient Satisfaction Level is measured with revised american pain society outcome questionnaire. 12 questions are present. |
| Assesment of quality of life: index | 15th and 30th post-operative day | Quality of life is measured with gastrointestinal quality of life index. there are 36 questions . it will measure quality of life after surgery. |
| Time taken to return to job and normal activities | 15-30 days | — |
| Hospital stay | 3-5 days | Time frame for hospital discharge |
Countries
Bangladesh
Outcome results
None listed