Actively Recruiting
Comparison of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
Led by Sardar Umer Rehman · Updated on 2026-02-24
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sardar Umer Rehman
Lead Sponsor
S
Services Institute of Medical Sciences, Pakistan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the effects of intraperitoneal bupivacaine instillation versus a placebo as preemptive pain relief in patients undergoing open appendectomy. The study focuses on evaluating pain management outcomes after surgery, specifically looking at postoperative pain within 24 hours. This is a phase 1 trial involving adult patients aged 20 to 60 undergoing emergency open appendectomy. Participants are randomly assigned to receive either 0.25% bupivacaine or 10 ml of normal saline instilled into the peritoneal cavity at the end of the operation. Both groups will have surgery duration noted, and pain relief and analgesic use will be monitored at 2, 6, 12, and 24 hours postoperatively. Rescue medications like ketorolac and nalbuphine will be used if pain scores reach certain levels. All patients will receive intravenous paracetamol as first-line analgesia. Patients are expected to be discharged two days after surgery once diet and pain are manageable, with additional oral pain medications provided if needed. During the study, researchers will closely record analgesic consumption and pain scores using a visual analogue scale. Follow-up will continue according to protocol to monitor ongoing pain and recovery. All information will be collected on a standardized form. The main outcome measured is postoperative pain within the first 24 hours. The trial aims to determine whether bupivacaine instillation offers better pain control compared to placebo during open appendectomy procedures.
CONDITIONS
Brief Title
Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting to the emergency department undergoing open appendectomy
- Age between 20 and 60 years
- Both males and females are eligible
You will not qualify if you...
- Patients undergoing interval appendectomy or with perforated appendix confirmed by physical exam and ultrasound
- Uncontrolled diabetes with blood sugar above 200 mg/dl or hypertension with blood pressure above 140/90
- History of chronic kidney disease, liver disease, psychiatric illness, or active peptic ulcer disease
- Alcohol use disorder
- History of chronic pain or current use of analgesic medications
- Pregnant females
- Allergy to bupivacaine or ketorolac
- Children, adolescents, or patients with mental illness
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 days
Participants undergo open appendectomy during which they receive either intraperitoneal Bupivacaine or normal saline as preemptive analgesia. Surgery duration is noted. Analgesic consumption and pain levels are monitored closely after surgery.
1 surgery visit and multiple assessments at 2, 6, 12, and 24 hours postoperatively
Duration - 3 to 4 days
Participants are monitored for pain and recovery after discharge. Oral analgesics are given if pain persists. Follow-up assessments are done as per protocol to record recovery progress and pain management.
1 to 2 follow-up visits after discharge
Trial Site Locations
Total: 1 location
1
Services Institute of Medical Sciences/ Services Hospital Lahore
Lahore, Punjab Province, Pakistan, 54000
Actively Recruiting
Research Team
D
Dr Sardar Umar Rehman, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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