Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery (U-IFB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01521481|
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Other: Triple inguinal nerve block. Other: Unilateral subarachnoid anesthesia||Phase 4|
Inguinal hernia repair accounts for 10-15% of all operations in general surgery. Moderate to severe pain can occur at the first day after inguinal hernia repair in 25% of patients at rest and in 60% during activity. On day 6 after the operation the incidence can be as high as 11% at rest and 33% during activity.
Ultrasound imaging for regional anesthesia techniques have improved the success and safety rate of nerve blocks. We hypothesized that a procedure consisting of an ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and incision line infiltration) could effectively control postoperative pain compared to selective unilateral subarachnoid anesthesia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analgesic Efficacy of Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||February 2012|
Experimental: Triple inguinal nerve block
Ropivacaine 5 mg/ml
Other: Triple inguinal nerve block.
Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
Other Name: Regional anesthesia for the groin.
Active Comparator: Unilateral subarachnoid anesthesia
Bupivacaine 10 mg/ml
Other: Unilateral subarachnoid anesthesia
Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Other Name: Regional anesthesia for the groin.
- Pain Intensity. [ Time Frame: Up to 24 hours. ]Postoperative pain will be assessed by numeric ranking scale (numeric ranking scale NRS 0 to 10 points) at rest (static numeric ranking scale NRS) and during activity (dynamic numeric ranking scale NRS).
- Supplemental local anesthesia infiltration [ Time Frame: During surgery, up to 2 hours. ]If needed, surgeons can infiltrate tissues with 15 ml of ropivacaine 5 mg/ml.
- Conversion to general anesthesia. [ Time Frame: During surgery, up to 2 hours ]Patients will receive remifentanil adjusted to maintain spontaneous breathing and conscious sedation with a Ramsay score = 2 during surgery if modest pain (numeric ranking scale NRS > 4 and agitation) is sustained. If remifentanil is not sufficient for restoring patient comfort, the block will be considered failed and the patient will be given general anesthesia with propofol and a Proseal Laryngeal Mask.
- mPADSS (Post-Anesthesia Discharge Scoring System) [ Time Frame: Up to 24 hours ]Assessed at every evaluation time postoperatively. The modified Post-Anesthesia Discharge Scoring System (mPADSS) includes stable heart and respiratory rates, absence of excessive nausea and pain, no bleeding from the surgical site, and ability to walk without support.
- Analgesic requirement [ Time Frame: Up to 7 days ]Assessed at every evaluation time postoperatively.
- Activity [ Time Frame: Up to 7 days ]Assessed through the activities assessment questionnaire 7 days after surgery.
- Adverse events. [ Time Frame: Up to 7 days ]Assessed at every evaluation time and including surgical and anesthesiological related events.
- Time from the end of anesthesia to first micturition. [ Time Frame: Up to 24 hours. ]Assessed at every evaluation time postoperatively.
- Time from the end of surgery to the first unassisted walking. [ Time Frame: Up to 24 hours. ]Assessed at every evaluation time postoperatively.
- Total intrahospital stay. [ Time Frame: Up to 24 hours. ]Assessed at every evaluation time postoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521481
|San Gerardo Hospital|
|Monza, Italy, 20900|
|Principal Investigator:||Zhirajr Mokini, M.D.||San Gerardo Hospital|
|Study Director:||Pablo Mauricio Ingelmo, M.D.||San Gerardo Hospital|