Abdominal Laparoscopic and/or Robotic Surgery, Bupivacaine, Lidocaine, Local Anasthesia, Post Operative Pain, Acute
Conditions
Keywords
Abdominal Laparoscopic Surgery, local anasthesia, Pain, lidocaine, Bupivacaine
Brief 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.
Interventions
DRUGLidocaine
10 mL lidocaine 2% administered intraoperatively by intraperitoneal instillation and port-site infiltration
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
Sponsors
Misr University for Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue opioid analgesia | Immediately after surgery, 2 hours after surgery, and 4 hours after surgery | Number of participants requiring rescue opioid analgesia for postoperative pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | 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. |
| Length of hospital stay | From admission until hospital discharge (up to 1 week) | Duration of hospitalization, measured from admission to discharge. |
| Surgery duration | During surgery | Duration of surgery measured in minutes from anesthesia induction until completion of wound dressing. |
Countries
Egypt
Outcome results
None listed