Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Sardar Umer Rehman
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Post operative pain
Overview
Brief Summary
To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients presenting to the emergency department undergoing open appendectomy.
Exclusion Criteria
- •Patients undergoing interval appendectomy or having perforated appendix as evident by examination (abdominal tenderness/ fever) and USG findings (presence of abscess, fluid collection, or free air).
- •Uncontrolled medical disease (DM: BSL \>200mg/dl, HTN: BP \>140/90)
- •History of chronic kidney or liver disease/ psychiatric illness/ Active peptic ulcer disease (as determined on history and medical records)
- •Alcoholics
- •History of chronic pain or patients on analgesic medications
- •Pregnant females
- •History of allergy to bupivacaine/ ketorolac as determined on history
- •Children, Adolescents and patients with mental illness.
Arms & Interventions
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.
Intervention: Bupivacain (Drug)
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.
Intervention: Normal Saline (Other)
Outcomes
Primary Outcomes
Post operative pain
Time Frame: 24 hours
Intensity of post operative pain by using visual analogue score and frequency of postoperative rescue analgesics if required after instillation of bupivacaine and placebo in both groups. Both outcomes will be noted at different intervals i.e. 2, 6, 12 and 24 hours postoperatively for comparison as mentioned.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sardar Umer Rehman
Principal Investigator
Services Institute of Medical Sciences, Pakistan