Bradycardia, Hypotension, Nausea, Post Operative Pain, Vomiting
Conditions
Keywords
Bupivacaine, Dexmedetomidine, Post operative analgesia, Abdominal surgery
Brief summary
Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.
Detailed description
This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.
Interventions
DRUGbupivacaine wound infilteration
drug was given at the end of surgery
DRUGBupivacaine plus dexmedetomidine wound infilteration
drug was given at the end of surgery
Sponsors
Sahiwal medical college sahiwal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both patients and assessor were unaware of interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age limit: 18-60 years 2. Gender of patient i.e., male or female 3. Patients listed for abdominal surgeries 4. American Society of Anesthesiologists (ASA) status of I or II
Exclusion criteria
1. Patients with history of drug allergy 2. Patients who undergone any analgesia in past 24 hr 3. Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment 4. American Society of Anesthesiologists (ASA) status III or IV 5. Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of analgesia | Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure | Time from procedure to requirement of rescue analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid sparing | Total dose of nalbuhine consumption in 1st 24 hrs after procedure | Total amount of opioid consumtion in the first 24 post procedure. |
| Blood pressure | Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively | Mean pressue will be measured |
| Hear rate | Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs | Heart rate will be measured |
| Neausea | Every 30 minutes for 4 hrs then 2hrly for 24 hrs | Felling of nasueas |
| Vomiting | Every 3 minutes for first 4 hrs then 2hrly for 24 hrs | Urge to vomit |
Countries
Pakistan
Outcome results
None listed