Clinical trial NCT00950625: Intraperitoneal Analgesia After Laparoscopic Cholecystectomy
Official title: Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: intraperitoneal analgesia
laparoscopic cholecystectomy
lignocaine
bupevacaine
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2009-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Control after Laparoscopic Cholecystectomy
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Requirement of Analgesia after laparoscopic cholecystectomy
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Muhammad R Khan, FRCS
role: PRINCIPAL_INVESTIGATOR
References: