Intraperitoneal Lidocaine and Bupivacaine for Postoperative Pain After Laparoscopic Surgery

NCT07775599 | Completed

• 1 other identifier: 2025/0099
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Abdominal Laparoscopic Surgery; local anasthesia; Pain; lidocaine; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Need for rescue opioid analgesia

  Number of participants requiring rescue opioid analgesia for postoperative pain.

  Immediately after surgery, 2 hours after surgery, and 4 hours after surgery

Secondary Outcomes (3)

• Postoperative pain intensity

  Immediately after surgery, 2 hours after surgery, and 4 hours after surgery

• Length of hospital stay

  From admission until hospital discharge (up to 1 week)

• Surgery duration

  During surgery

Study Arms (2)

Local Anesthetic Group

ACTIVE COMPARATOR

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

Saline Group

PLACEBO COMPARATOR

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

Lidocaine DRUG

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

Local Anesthetic Group

Placebo Normal Saline (NS) OTHER

Intraoperative intraperitoneal instillation and port-site infiltration of normal saline

Saline Group

Bupivacaine DRUG

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

Local Anesthetic Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

The Memorial Souad Kafafi University Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 20, 2026
• Study Start: August 6, 2025
• Primary Completion: July 5, 2026
• Study Completion: July 5, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)