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

NCT07429448 | Recruiting Phase 1

• 1 other identifier: 14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Appendectomy

Keywords

Analgesia; Bupivacaine; Open Appendectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (2)

Group A participants who will receive Bupivacaine Intraperitoneally

EXPERIMENTAL

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.

Drug: Bupivacain

Group B participants who will receive 10 ml of normal saline Intraperitoneally

ACTIVE COMPARATOR

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.

Other: Normal Saline

Interventions

Bupivacain DRUG

Bupivacaine with 0.25% of concentration at the end of the operation intraperitoneally.

Group A participants who will receive Bupivacaine Intraperitoneally

Normal Saline OTHER

10ml of Normal Saline at the end of the operation intraperitoneally.

Group B participants who will receive 10 ml of normal saline Intraperitoneally

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients presenting to the emergency department undergoing open appendectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sardar Umer Rehman: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

Services Institute of Medical Sciences/ Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Dr Sardar Umar Rehman, MBBS

CONTACT

+923319326657; umersardar578@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)