Pain, Postoperative
Conditions
Keywords
Regional anesthesia, Erector spinae plane block, Post-operative analgesia, Laparoscopy, Open surgery, Colorectal surgery
Brief summary
In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.
Detailed description
Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period. In this study, the hypothesis was determined as Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores. The patients were divided into two groups : Group ESP (erector spinae plan): In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours. Group GA (general anesthesia): In this group, patients will be administered only IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
Interventions
PROCEDUREErector spina plane block + general anesthesia
Bilateral-injection ultrasound-guided bilateral erector spinae plane block Pre-operatively, with the patient in the sitting position, 20ml 0.25% bupivacaine will be administered between the T9 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane. The same procedure was applied bilaterally. Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied. Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose. Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score \>3, (max doses 300 mg/day).
PROCEDUREOnly general anesthesia
Intraoperative analgesia: After anesthesia induction tenoxicam 20 mg IV and 30 min. before the end of the surgery paracetamol (1gr) iv was applied. Postoperative analgesia: IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose. Rescue analgesia was provided with iv tramadol 30 mg boluses whenever the Visual analog scale pain score \>3, (max doses 300 mg/day).
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients were randomly divided into two groups of 30 patients each. In the system where computer generated random numbers (SPSS v23.0, IBM, NewYork, USA) were used, ESP and GA groups were determined at a ratio of 1:1. Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the block procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group. The care provider and investigator were also blinded to the participant.
Intervention model description
Our study is a single center, prospective, randomized controlled, single-blinded, parallel group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 65 years * ASA I , II patients * BMI\<35 kg/m2 (body weight \<100 kg , \>45 kg) * Patients who underwent colorectal surgery
Exclusion criteria
* Patients who underwent abdominoperineal resection * Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied. * Patients diagnosed with OSAS * Pregnancy and breastfeeding * Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site) * Hypersensitivity to local anesthetics or a history of allergy * Patients with a history of opioid use longer than four weeks * Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient. * Patients with anatomic deformity ( advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity ) * Patients who do not want to participate * Patients who have had previous colorectal surgery, excluding diagnostic biopsies * Patients who could not be reached by phone to inquire about their pain score at 3rd month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine consumption in the first 24 hours | Postoperative day 1 | Morphine consumption in the first 24 hours were measured. Patients will be able to request opioids via a PCA device when their VAS score is above 3 at rest and during activity (coughing and deep breathing). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patient requiring rescue analgesia | Postoperative day 1 | The number of patients who required rescue analgesics were recorded at 0, 1, 3, 6, 12 and 24. hours after extubation |
| Number of patients with postoperative nausea-vomiting and need of antiemetic usage | Postoperative day 1 | The severity of postoperative nausea and vomitting (PONV) was assessed using a descriptive verbal rating scale at 0, 1, 3, 6, 12 and 24 hours after extubation. If a score of 2 or more granisetron 1,5 mg iv will be administered. The PONV scale 0= no nausea, 1= slight nausea 2= moderate nausea, 3= vomiting once, 4= vomiting more than once |
| Postoperative pain scores | Postoperative month 3 | Pain status at rest and while activity (coughing and deep breathing) were assessed by VAS scores at 0, 1, 3, 6, 12, 24 hours and 3th month after extubation. The VAS is an 11 point numeric scale which ranges from 0 to 10 at rest and during activity. |
| Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time | Postoperative 7 days on an average | Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time were recorded |
| Incidence of pruitus | Postoperative day 1 | Number of patient with pruitus were recorded at 0, 1, 3, 6, 12 and 24. hours |
| Remifentanil consumption during the surgery | The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min] | The total amount of remifentanil consumed will be recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed