Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:
• Patients presenting to the emergency department undergoing open appendectomy.
Locations
Other Locations
Pakistan
Services Institute of Medical Sciences/ Services Hospital Lahore
RECRUITING
Lahore
Contact Information
Primary
Dr Sardar Umar Rehman, MBBS
umersardar578@gmail.com
+923319326657
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2026-06-16
Participants
Target number of participants: 60
Treatments
Experimental: Group A participants who will receive Bupivacaine Intraperitoneally
This group consists of 30 participants and will receive Bupivacaine with 0.25% of concentration intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma.
Active_comparator: Group B participants who will receive 10 ml of normal saline Intraperitoneally
This group consists of 30 participants and will receive 10 ml of Normal Saline intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma.
Related Therapeutic Areas
Sponsors
Leads: Sardar Umer Rehman
Collaborators: Services Institute of Medical Sciences, Pakistan