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Completed

NCT Number: NCT07775599

Intraperitoneal Lidocaine and Bupivacaine for Postoperative Pain After Laparoscopic Surgery

The goal of this clinical trial is to determine the safety and efficacy of combined intraperitoneal local anesthetic instillation and port-site infiltration using lidocaine and bupivacaine in adults aged 18 to 60 undergoing elective laparoscopic abdominal surgeries (such as laparoscopic cholecystectomy, appendectomy, or hernia repair). The main questions it aims to answer are: Does combined intraperitoneal local anesthetic instillation and port-site infiltration reduce immediate and early (up to 4 hours) postoperative pain scores? Does this intervention reduce the early need for additional postoperative analgesics and shorten the length of hospital stay? Researchers will compare the treatment group receiving lidocaine (2%) and bupivacaine (0.5%) by intraperitoneal instillation and port-site infiltration with a control group receiving normal saline by the corresponding routes to determine whether the local anesthetic intervention reduces postoperative pain and analgesic requirements. Participants will undergo scheduled elective laparoscopic abdominal surgery and receive either the local anesthetic intervention or normal saline during the surgical procedure. Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery in the recovery room and again at 2 and 4 hours after surgery. Analgesic needs will be monitored and documented, and total hospital stay will be recorded.

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Key information

Conditions

Abdominal Laparoscopic and/or Robotic Surgery Bupivacaine Lidocaine Local Anasthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain, Acute Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Memorial Souad Kafafi University Hospital

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 60 years.
  • Scheduled for laparoscopic abdominal surgery (e.g., laparoscopic cholecystectomy, laparoscopic appendectomy, or laparoscopic hernia repair).
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • No history of chronic pain, opioid dependence, or severe medical comorbidities.
  • Able and willing to provide written informed consent.

Exclusion criteria

  • Conversion from laparoscopic to open surgery.
  • Acute cholecystitis, gangrene, or empyema of the gallbladder.
  • Oncologic or extensive laparoscopic procedures expected to have a prolonged operative time.
  • Known allergy or hypersensitivity to lidocaine, bupivacaine, or other local anesthetic agents.
  • Diabetes mellitus.
  • Current systemic corticosteroid use.
  • Pregnancy.
  • Cardiac, pulmonary, hepatic, or renal disorders.
  • History of opioid use or opioid dependence.

Treatment and study plan

Lidocaine

Drug

10 mL lidocaine 2% administered intraoperatively by intraperitoneal instillation and port-site infiltration

Placebo Normal Saline (NS)

Other

Intraoperative intraperitoneal instillation and port-site infiltration of normal saline

Bupivacaine

Drug

10 mL bupivacaine 0.5% administered intraoperatively by intraperitoneal instillation and port-site infiltration

Primary outcomes

  1. Need for rescue opioid analgesia

    Time frame: Immediately after surgery, 2 hours after surgery, and 4 hours after surgery

    Number of participants requiring rescue opioid analgesia for postoperative pain.

Secondary outcomes

  1. Postoperative pain intensity

    Time frame: Immediately after surgery, 2 hours after surgery, and 4 hours after surgery

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain intensity.

  2. Length of hospital stay

    Time frame: From admission until hospital discharge (up to 1 week)

    Duration of hospitalization, measured from admission to discharge.

  3. Surgery duration

    Time frame: During surgery

    Duration of surgery measured in minutes from anesthesia induction until completion of wound dressing.

Sponsors and collaborators

Lead sponsor

Misr University for Science and Technology

Other

Registry information

Official study title

The Effectiveness of Intraperitoneal Lidocaine and Bupivacaine Instillation for Reducing Postoperative Pain in Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

Acronym: IPLA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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