Nerve Block, Pain, Postoperative
Conditions
Keywords
celiac plexus block
Brief summary
This subject intends to explore the value of intraoperative celiac plexus block in postoperative acute pain management and its promoting effect on patients' rapid recovery during Whipple surgery through a randomized controlled trial.
Detailed description
This study is a single center, randomized, single-blind controlled study. After calculating the sample size, 66 subjects would be randomly assigned to nerve block group (NB group: local anesthetic injection at the target position) and blank control group (GC group: no celiac plexus block) according to the ratio of 1:1, in order to evaluate the effectiveness and safety of celiac plexus block (CPB) as a part of multimodal analgesia for postoperative pain management. Anesthesia protocol: the standard anesthesia protocol for open Whipple surgery in our hospital was adopted. Postoperative analgesia plan: before abdominal closure at the end of operation, The surgeon was instructed to perform a single celiac plexus block (CPB) under direct vision. Ropivacaine was injected into the target nerve in NB group, but no injection in GC group. After the operation, the anesthesiologist used ropivacaine to perform ultrasound-guided abdominal wall nerve block. When leaving the operating room, connect intravenous analgesia pump. Patients with subjective pain score of 3 or above can press. If the analgesia is insufficient, intravenous injection of dezocine can be added temporarily. The intravenous analgesia pump shall be withdrawn after 72 hours of use. If the analgesia pump is used up and is still needed, the anesthesiologist can evaluate and add medicine.
Interventions
PROCEDURECeliac plexus block
The surgeon is instructed to perform a single celiac plexus block under direct vision. 10ml 0.5% ropivacaine is injected into the nerve in both sides.
DRUGRopivacaine
Mixed solution for nerve block, made of 0.75% ropivacaine (Naropin, Astrazeneca AB) diluted in different proportions.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18years; 2. received open Whipple surgery.
Exclusion criteria
1. patients unable to cooperate with evaluations; 2. patients with history of drug abuse, local anesthetic allergy, anatomical variation of the celiac ganglia indicated by abdominal CT, abdominal aortic diseases; 3. non-standard surgical procedures, planned postoperative ICU admission; 4. American Society of Anesthesiologists (ASA) classification of 4 or 5. Withdrawal criteria: Patients who underwent unplanned surgeries, required reintubation or a second surgery, received ICU care within three days post-surgery, died within two weeks post-surgery, or experienced any unexpected events were withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 72 hours after surgery | Morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic vascular resistance index changes during celiac plexus block | Before and 5、10、20 minutes after CPB | Celiac plexus block (CPB) |
| Press of the analgesic pump | Every 24 hours post-surgery for 72 hours | Daily frequency of pump presses |
| Time to first flatus | 72 hours after surgery | — |
| Length of postoperative hospitalization | After surgery to before discharge, up to 2 months | — |
| White blood cell count | At the end of surgery and 24 hours post-surgery | Laboratory tests of white blood cell count (WBC) |
| C-reactive protein | At the end of surgery and 24 hours post-surgery | Laboratory tests of C-reactive protein (CRP) |
| Postoperative mean arterial pressure | Every 12 hours post-surgery for 72 hours | Mean arterial pressure (MAP) |
| Interleukin-6 | At the end of surgery and 24 hours post-surgery | Laboratory tests of interleukin-6 (IL-6) |
| Procalcitonin | At the end of surgery and 24 hours post-surgery | Laboratory tests of procalcitonin (PCT) |
| Pain scores | 6, 12, 24, 48, 72 hours after surgery | VAS (0 indicates no pain and score 10 indicates the most severe pain) |
| Cardiac index changes during celiac plexus block | Before and 5、10、20 minutes after CPB | Celiac plexus block (CPB) |
| Postoperative heart rate | Every 12 hours post-surgery for 72 hours | Heart rate (HR) |
| Erythrocyte sedimentation rate | At the end of surgery and 24 hours post-surgery | Laboratory tests of erythrocyte sedimentation rate (ESR) |
Countries
China
Outcome results
None listed