Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

San Gerardo Hospital

Status and phase: Completed; Phase 3

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: Saline; Drug: Ropivacaine 30 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01247857

AR HSG 02-2008

Details and patient eligibility

About

Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.

Full description

Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.

The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA Score I-III
• Scheduled for laparoscopic cholecystectomy
• Free from pain in preoperative period
• Not using analgesic drugs before surgery
• Without cognitive impairment or mental retardation
• Written informed consent

Exclusion criteria

• Emergency/urgency surgery
• Postoperative admission in an intensive care unit
• Cognitive impairment or mental retardation
• Progressive degenerative diseases of the CNS
• Seizures or chronic therapy with antiepileptic drugs
• Severe hepatic or renal impairment
• Pregnancy or lactation
• Allergy to one of the specific drugs under study
• Acute infection or inflammatory chronic disease
• Alcohol or drug addiction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

Preoperative Nebulization

Active Comparator group

Description:

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery

Treatment:

Drug: Ropivacaine 30 mg

Drug: Ropivacaine 30 mg

Postoperative Nebulization

Active Comparator group

Description:

Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery

Treatment:

Drug: Ropivacaine 30 mg

Drug: Ropivacaine 30 mg

Control

Placebo Comparator group

Description:

Nebulization of normal saline 3 ml before and after surgery

Treatment:

Drug: Saline