NCT02707250

Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.

Detailed description

Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects. The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy . Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used . Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Placebo	Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side
DRUG	Bupivacaine	Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.
DRUG	Pethidine	Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side
DRUG	Pethidine Local Infiltration (L.I)	Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-06-01
• First posted: 2016-03-14
• Last updated: 2016-03-14

Locations

1 site across 1 country: Romania