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Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950625
Enrollment
200
Registered
2009-08-03
Start date
2009-08-31
Completion date
2010-08-31
Last updated
2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Keywords

intraperitoneal analgesia, laparoscopic cholecystectomy, lignocaine, bupevacaine

Brief summary

Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy. If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.

Interventions

200 mg of intraperitoneal lignocaine will be given once during surgery

DRUGbupevacaine

100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy * Elective surgical procedure * American Society of Anesthesiologists class I and II

Exclusion criteria

* Patients refusing randomization * Patients already on analgesics * Patients with acute cholecystitis * Patients requiring preoperative cholangiogram or common bile duct exploration * Patients having bile or stone spillage during procedure * Patients requiring conversion to open procedure * Patients requiring re-exploration for any reason * Patients with history of allergy to local anesthetic agents

Design outcomes

Primary

MeasureTime frame
Pain Control after Laparoscopic Cholecystectomy24 hours after surgery

Secondary

MeasureTime frame
Requirement of Analgesia after laparoscopic cholecystectomy24 hours after surgery

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026