Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy

ConditionAppendectomy

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age20-60

SponsorSardar Umer Rehman

About this trial

To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting to the emergency department undergoing open appendectomy.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Bupivacain
Drug
Bupivacaine with 0.25% of concentration at the end of the operation intraperitoneally.
Normal Saline
Other intervention
10ml of Normal Saline at the end of the operation intraperitoneally.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Group A participants who will receive Bupivacaine IntraperitoneallyExperimental treatment 1 intervention

Group B: Group B participants who will receive 10 ml of normal saline IntraperitoneallyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Post operative pain

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.

Time frame

24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sardar Umer Rehman

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Sponsor institution

Services Institute of Medical Sciences, Pakistan

Collaborator

Source ClinicalTrials.gov

Apply now