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
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.
Exclusion Criteria:
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
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)
10 mL lidocaine 2% administered intraoperatively by intraperitoneal instillation and port-site infiltration
Intraoperative intraperitoneal instillation and port-site infiltration of normal saline
10 mL bupivacaine 0.5% administered intraoperatively by intraperitoneal instillation and port-site infiltration
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
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
Length of hospital stay
Duration of hospitalization, measured from admission to discharge.
Time frame: From admission until hospital discharge (up to 1 week)
Surgery duration
Duration of surgery measured in minutes from anesthesia induction until completion of wound dressing.
Time frame: During surgery
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Misr University for Science and Technology