Clinical trial NCT06531603: Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery
Official title: Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Post Operative Pain
Bradycardia
Hypotension
Nausea
Vomiting
Keywords: Bupivacaine
Dexmedetomidine
Post operative analgesia
Abdominal surgery
Lead sponsor: Sahiwal medical college sahiwal
Sponsor class: OTHER_GOV
First posted: 2024-08-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of analgesia
timeFrame: Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure
Secondary outcomes:
measure: Opioid sparing
timeFrame: Total dose of nalbuhine consumption in 1st 24 hrs after procedure
measure: Blood pressure
timeFrame: Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively
measure: Hear rate
timeFrame: Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs
measure: Neausea
timeFrame: Every 30 minutes for 4 hrs then 2hrly for 24 hrs
measure: Vomiting
timeFrame: Every 3 minutes for first 4 hrs then 2hrly for 24 hrs
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: Sahiwal Medical College
state: Punjab
Study officials:
affiliation: Sahiwal medical college sahiwal
name: M. Shahid, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahiwal medical college sahiwal
name: A. Riaz, MD
role: STUDY_DIRECTOR
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