Postoperative Pain
Conditions
Keywords
Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia
Brief summary
The purpose of the study is to assess whether spinal anesthesia is superior to the standard general anesthesia or not for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
Detailed description
Anesthesia for laparoscopic procedures, including transabdominal preperitoneal inguinal hernia repair(TAPP) is synonymous with general anesthesia because of the adverse effects of the CO2 pneumoperitoneum on the awake patient, and regional anesthesia is preferred only in patients where general anesthesia is contraindicated. Α pilot study of our hospital has recently shown the feasibility to perform successfully and safely transabdominal preperitoneal inguinal hernia repair with low pressure CO2 pneumoperitoneum under spinal anesthesia.After this pilot study and based on previous experience in regional anesthesia for laparoscopic procedures, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for patients undergoing transabdominal preperitoneal inguinal hernia repair (TAPP).
Interventions
PROCEDURETransabdominal Preperitoneal repair of inguinal hernia
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
Sponsors
University of Thessaly
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-III * BMI ≤ 35 * Age ≥ 18 * Normal coagulation profile
Exclusion criteria
* Non-reducible/obstructed hernias * Previous open surgery in the lower abdomen * Contraindication for pneumoperitoneum * Contraindication for spinal or/and general anesthesia * History of chronic pain or daily intake of analgesics * Psychiatric disorders * Inability of patients to use PCA pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption | Every 8 hours | The total dose of morphine was calculated as mg and administered by PCA pump |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side- effects | Every 8 hrs | To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc |
| Hospital stay | Patients will be followed for the duration of hospital stay | — |
| Patient satisfaction | 2 weeks after the operation | — |
| Postoperative pain | Every 8 hrs | NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain) |
| Quality of life | 6 months after the operation | SF 36 questionnaire |
| Complications | 1 year | seroma, hematoma, infection, recurrence of hernia, etc |
| Chronic Pain | 12 months after the operation | — |
Countries
Greece
Outcome results
None listed