Intraperitoneal Lidocaine and Bupivacaine for Postoperative Pain After Laparoscopic Surgery

Misr University for Science and Technology64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Abdominal Laparoscopic and/or Robotic Surgery

Interventions

LidocaineDRUG

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

BupivacaineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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