Pancreatic Ductal Adenocarcinoma, Liver, Cancer of, Primary Resectable
Conditions
Keywords
laparoscopic hepato-pancreato-biliary surgery
Brief summary
The goal of this study is to assess the efficacy of intraoperative celiac plexus block (CPB) to reduce opioid consumption following laparoscopic hepato-pancreato-biliary surgery
Detailed description
A bilateral CPB is convenient and safe to perform under the direct laparoscopic vision of the surgeons during surgery; however, perspective data are warranted. The investigators hypothesize that a bilateral CPB using 0.5% ropivacaine will improve the quality of recovery following a laparoscopic hepato-pancreato-biliary surgery. The primary endpoint is the Postoperative opioid use. Secondary endpoints include acute postoperative pain, opioid consumption, the incidence of postoperative nausea or vomiting (PONV), the 15-item quality of recovery questionnaire (QoR-15), length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay, and chronic post-surgical pain at 90 d after surgery.
Interventions
DRUGRopivacaine 0.5%
Prior to the end of the laparoscopic surgery and any additional procedures, the bilateral celiac plexus block will be performed by the surgeon after identification of the aorta at the superior border of body of pancreas. A 22-gauge spinal needle will be inserted into the retroperitoneal fat on either side of the aorta under direct vision. Needle aspiration will be performed to exclude entry into vessels before administration of the interventional drug. The block will contain 20 mL of 0.5% ropivacaine hydrochloride + 1:400000 adrenaline.
DRUGNormal Saline
Prior to the end of the laparoscopic surgery and any additional procedures, the bilateral celiac plexus block will be performed by the surgeon after identification of the aorta at the superior border of body of pancreas. A 22-gauge spinal needle will be inserted into the retroperitoneal fat on either side of the aorta under direct vision. Needle aspiration will be performed to exclude entry into vessels before administration of the interventional drug. The block will contain 20 ml of 0.9% normal saline + 1:400000 adrenaline.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over age 18 * Undergoing laparoscopic hepato-pancreato-biliary surgery
Exclusion criteria
* Patient refuse * Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history * Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment * Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months * Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid use | Up to 24 h after surgery | The primary outcome will be morphine equivalent during the first postoperative 24 h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) for pain | Up to 72 h after surgery | Patients will be asked to complete a daily diary up to 72 h that records numeric pain rating scale |
| Postoperative vomiting | Up to 72 h after surgery | Incidence of postoeprative vomiting will be recorded for up to 72 h |
| Postoperative opioid use | Up to 72 h after surgery | Patients will be recorded for up to 72 h postoperative opioid consumption. |
| Post-anesthesia care unit (PACU) time | Through study completion, an average of 1 year | Length of PACU stay |
| Post-operative hospital time | Through study completion, an average of 1 year | Length of hospital stay |
| Quality of recovery using the 15-item quality of recovery questionnaire (QoR-15) | Up to 72 h after surgery | Patients will be asked to complete a 15-item quality of recovery questionnaire up to 72 h after surgery |
Contacts
Primary ContactHu
Backup ContactGuo
Outcome results
None listed