Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
- Conditions
- Gallstone DiseasePost-operative Pain
- Interventions
- Procedure: CTB groupProcedure: PCIA group
- Registration Number
- NCT02300480
- Lead Sponsor
- First Affiliated Hospital of Chongqing Medical University
- Brief Summary
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. So the purpose of this study is to determine whether Calot's Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing the incidence of chronic pain after LC.
- Detailed Description
Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.
Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.
Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.
The primary outcome of this study is the incidence of chronic pain after LC.
The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.
This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.
- age below 18 years or over 65 years
- American Society of Anesthesiologists grade III or greater
- Diabetes
- chronic pain of any kind other than gallbladder disease
- allergic to local anesthetics
- cognitive impairment or communication problems
- peptic ulcer
- received opioids、NSAID or tranquilizers (treatment for over 1 wk before the cholecystectomy)
- history of alcohol or drug abuse
- the operation was converted to an open procedure
- gangrenous cholecystitis
- common bile duct exploration or insertion of a T-drain
- other invasive procedures
- severe hepatic or renal impairment
- post-operative severe complications(e.g. pyogenic infection)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTB group CTB group Participants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively. CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total. PCIA group PCIA group Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
- Primary Outcome Measures
Name Time Method Chronic post-surgical pain 3 months post-operatively Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
- Secondary Outcome Measures
Name Time Method Acute pain post-operatively 2h,4h,6h,12h,24h, 48h post-operatively Pain intensity will be measured by visual analogue scale(VAS)
Analgesic Rescue from 2h to 48h post-operatively The dosages of opioid or non-opioid analgesic rescue medications
Adverse events associated with post-operative analgesia from 2h to 48h post-operatively incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
moderate-severe pain 3,6months postoperatively Pain intensity will be measured by numerical rating scale (NRS)
chronic post-surgical pain 6months postoperatively chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain
Trial Locations
- Locations (1)
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China