| Registry | NCT03606889 |
|---|---|
| Status | Terminated - not enough participants |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Jagiellonian University (Other) |
| Conditions | Prostatic Cancer, Pain, Postoperative, Pain, Anesthetics, Local |
| Interventions | Quadratus Lumborum block, Tranversus Abdominis plane block, Bupivacaine (Diagnostic test, drug) |
| Dates | start 2018-07-31, primary completion 2021-12-31, completion 2021-12-31, first posted 2018-07-31, last updated 2022-06-06 |
| Locations | 1 site in Poland |
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Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy.
Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.
In laparoscopic prostatectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic prostatectomy may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Quadratus Lumborum block group | Experimental | Diagnostic Test: Quadratus Lumborum block; Drug: Bupivacaine | Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125% |
| Transversus abdominis plane block group | Experimental | Diagnostic Test: Tranversus Abdominis plane block; Drug: Bupivacaine | Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125% |
Sex: Male, ages: 18 Years to 90 Years
Inclusion Criteria: * Pateints who will have prostatectomy ASA II or III Exclusion Criteria: Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia \-
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital in Cracow | Krakow | Poland |