Acute Pain, Analgesia, Anesthesia, Patient Controlled Analgesia
Conditions
Keywords
Regional Anesthesia, Acute Pain Scores, Subcostal Anterior Quadratus Lumborum Block, Thoracic Paravertebral Block, Morphine Consumption
Brief summary
In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and thoracic paravertebral block (TPVB) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.
Detailed description
Laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. Acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. Poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications. Facial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. Quadratus lumborum (QL) block is a relatively new technique. Subcostal anterior QL block (S-QLB3) involves injection in the plane between the psoas and QL muscles. Thoracic paravertebral block (TPVB) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. It has been used successfully as part of multimodal analgesia in renal surgery. In this study, it was aimed to evaluate the effects of S-QLB3 block and TPVB block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy. Patients will be divided into two groups: Group S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours. Group TPVB: A unilateral TPV block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
Interventions
S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM. 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.
PROCEDUREThoracic Paravertebral Block
TPVB block will be performed 30 min. before general anesthesia. TPVB will be performed at T10 transverse process level, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the paravertebral space. 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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based Research Randomizer (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
Intervention model description
A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-II patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical)
Exclusion criteria
* Age \<18y, \>70y * Obesity (BMI\> 30 kg / m2) * Pregnancy * Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site) * Serious cardiac, hepatic, and cerebrovascular disease * Hypersensitivity to local anesthetics or a history of allergy * Patients with a history of opioid use longer than four weeks * Patients with psychiatric disorders or communication difficulties * Patients who do not want to participate * Asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption in the first 24 hours after surgery | Postoperative Day 1 | Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score is above 3 at rest and during activity (coughing and deep breathing). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative acute pain | Postoperative Day 1 | Pain status at rest and while activity (coughing and deep breathing) will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The number of patient required antiemetic | Postoperative Day 1 | The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv will be administered. |
| 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 240 min | The total amount of remifentanil consumed will be recorded. |
| Incidence of complications related to block | Postoperative 7 days on an average | Complications associated with S-QLB3 and TPVB block (such as visceral organ injury, pneumothorax, retroperitoneal-paravertebral hematoma, lower extremity-quadriceps weakness, vascular puncture, epidural invasion, intrathecal injection and LAST) will be recorded. |
| Patients' satisfaction and quality of pain management | Postoperative Day 1 | Patients' satisfaction and quality of pain management will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version |
| The heart rate measurement | The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min. | The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit. |
| The mean arterial pressure measurement | The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min. | The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit. |
| The number of patient required rescue analgesia | Postoperative Day 1 | The number of patients requiring rescue analgesics will be recorded over 24 hours. |
| The incidence of side effects related to opioid use | Postoperative Day 1 | Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression will be recorded. |
Countries
Turkey (Türkiye)
Outcome results
None listed