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CompletedNCT07775599IPLAUpdated Aug 20, 2026

Intraperitoneal Lidocaine and Bupivacaine for Postoperative Pain After Laparoscopic Surgery

An interventional study of Lidocaine and Placebo Normal Saline (NS) in Abdominal Laparoscopic and/or Robotic Surgery, Local Anasthesia and Post Operative Pain, Acute, sponsored by Misr University for Science and Technology. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Misr University for Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Abdominal Laparoscopic and/or Robotic Surgery
  • Local Anasthesia
  • Post Operative Pain, Acute
  • Lidocaine
  • Bupivacaine

Keywords

  • Abdominal Laparoscopic Surgery
  • local anasthesia
  • Pain
  • lidocaine
  • Bupivacaine
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    Local Anesthetic Group

    Participants in this arm will receive a total of 20 mL of study solution prepared by combining 10 mL of 2% lidocaine with 10 mL of 0.5% bupivacaine. The resulting 20-mL mixture will be divided equally between the intraperitoneal and port-site routes: 10 mL will be instilled intraperitoneally over the surgical bed, while the remaining 10 mL will be equally distributed among the trocar wounds for port-site infiltration.

    Drug: Lidocaine · Drug: Bupivacaine

  • Placebo comparator
    Saline Group

    Participants in this arm will receive a total of 20 mL of normal saline, divided equally between intraperitoneal instillation and port-site infiltration: 10 mL will instilled intraperitoneally over the surgical bed, while the remaining 10 mL will equally distributed among the trocar wounds.

    Other: Placebo Normal Saline (NS)

Interventions

  • DrugLidocaine

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

  • OtherPlacebo Normal Saline (NS)

    Intraoperative intraperitoneal instillation and port-site infiltration of normal saline

  • DrugBupivacaine

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

05

What researchers measure

Primary outcomes

  1. Need for rescue opioid analgesia

    Number of participants requiring rescue opioid analgesia for postoperative pain.

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

Secondary outcomes

  1. Postoperative pain intensity

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

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

  2. Length of hospital stay

    Duration of hospitalization, measured from admission to discharge.

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

  3. Surgery duration

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

    Time frame: During surgery

06

Study locations

1 site
  • The Memorial Souad Kafafi University Hospital
    Giza, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07775599
Lead sponsor
Misr University for Science and Technology
Responsible party
Mohamed Ahmed Tolba Abdelsalam (Assistant Lecturer, Misr University for Science and Technology) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 6, 2025
Primary completion
Jul 5, 2026
Completion
Jul 5, 2026
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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