Postoperative Pain
Conditions
Keywords
erector spinae block, TAP Block, abdominal surgery
Brief summary
The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.
Detailed description
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction. The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked. Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block. Both blocks haven't been compared to each other in this type of surgery before.
Interventions
PROCEDURElower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.
OTHERErector spinae plane block
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
OTHERTransversus abdominis plane block
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Physical status ASA II. * Age ≥ 18 and ≤ 65 Years. * Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures). * Patient is able to provide a written informed consent. * Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.
Exclusion criteria
* Age \<18 years or \>65 years. * BMI \<20 kg/m2 and \>40 kg/m2. * Known sensitivity to local anaesthetics and morphine. * History of psychological disorders and/or chronic pain. * Significant liver or renal insufficiency. * Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy. * Patient refusal. * Severe respiratory or cardiac disorders. * Pregnancy. * ASA III-IV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 24 hours | The total amount of morphine which was consumed post-operatively measured in milligrams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl consumption. | intraoperative | The total amount of fentanyl which was consumed during the surgery measured in milligrams |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 24 hours | the number of heart beats in one minute |
| Postoperative nausea and vomiting | 24 hours postoperative | the number of patients who had nausea and vomiting |
| mean arterial blood pressure | 24 hours | the mean arteiral blood pressure measurend in mmHg |
| Numerical rating scale for pain assessment. | 24 hours | This is a numerical rating scale for pain assessment which ranges from 0 to 10 with the least pain at scale 0 and the worst pain at scale 10 |
| Time for first rescue analgesia. | 24 hours postoperative | the time at which the patient will request an analgesic |
Countries
Egypt
Contacts
Primary Contactahmed hasanin, Professor
Backup Contactahmed zaghloul, Professor
Outcome results
None listed