Intraperitoneal bupivacaine versus saline to reduce pain after open appendectomy
Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
PHASE1 · Services Institute of Medical Sciences, Pakistan · NCT07429448
This will test whether placing bupivacaine into the abdominal cavity during open appendectomy reduces postoperative pain more than saline for adults who come to the emergency department.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Services Institute of Medical Sciences, Pakistan (other gov) |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07429448 on ClinicalTrials.gov |
What this trial studies
In this Phase 1 interventional study, adults undergoing emergency open appendectomy receive intraperitoneal instillation of either bupivacaine or normal saline as preemptive analgesia. Clinical outcomes related to postoperative pain and immediate recovery are compared between the two groups. Key exclusions include perforated appendix, uncontrolled medical disease, chronic pain or analgesic use, pregnancy, and allergy to bupivacaine. The trial is conducted at Services Hospital Lahore under the lead sponsor Sardar Umer Rehman.
Who should consider this trial
Good fit: Adults presenting to the emergency department for open appendectomy who do not have perforation, uncontrolled medical illness, chronic pain or analgesic use, pregnancy, or allergy to bupivacaine are the intended participants.
Not a fit: Patients with perforated appendicitis, uncontrolled medical conditions, chronic pain or chronic analgesic use, pregnant women, children, and those allergic to bupivacaine are excluded and therefore unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients could have less postoperative pain and need fewer opioid pain medications after open appendectomy.
How similar studies have performed: Intraperitoneal local anesthetic instillation has been used in other abdominal surgeries with mixed but often positive effects on postoperative pain, while its specific application in open appendectomy is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lahore, Punjab Province
- Services Institute of Medical Sciences/ Services Hospital Lahore — Lahore, Punjab Province, Pakistan (RECRUITING)
Study contacts
- Study coordinator: Dr Sardar Umar Rehman, MBBS
- Email: umersardar578@gmail.com
- Phone: +923319326657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Appendectomy, Analgesia, Bupivacaine, Open Appendectomy