Postoperative PainNCT01520857
Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
A study testing Transabdominal Preperitoneal repair of inguinal hernia in people with Postoperative Pain, run by Larissa University Hospital at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Transabdominal Preperitoneal repair of inguinal hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- BMI ≤ 35
- Age ≥ 18
- Normal coagulation profile
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
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).
Read the 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).
- Conditions
- Postoperative Pain
- Being tested
- Transabdominal Preperitoneal repair of inguinal hernia
- Keywords
- Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal Preperitoneal repair of inguinal herniaProcedure or surgery
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
Transabdominal Preperitoneal repair of inguinal herniaProcedure or surgery
Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Active comparator | Transabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia Receives: Procedure: Transabdominal Preperitoneal repair of inguinal hernia |
| General Anesthesia | Active comparator | Transabdominal Preperitoneal repair of inguinal hernia. general anesthesia Receives: Procedure: Transabdominal Preperitoneal repair of inguinal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
The total dose of morphine was calculated as mg and administered by PCA pump
Measured: Every 8 hours
Secondary outcomes (7)
Postoperative pain
NRS = numeric rating scale 0-10 mm (0=no pain to 10= worst imaginable pain)
Measured: Every 8 hrs
Side- effects
To determine the occurrence of side effects such as postoperative nausea,vomiting, itching, headache, shoulder pain, urinary retention, etc
Measured: Every 8 hrs
Hospital stay
Measured: Patients will be followed for the duration of hospital stay
Patient satisfaction
Measured: 2 weeks after the operation
Chronic Pain
Measured: 12 months after the operation
Quality of life
SF 36 questionnaire
Measured: 6 months after the operation
Complications
seroma, hematoma, infection, recurrence of hernia, etc
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, Chamaidi Sarakatsianou, Larissa University Hospital
- Investigators
- Chamaidi Sarakatsianou, RN,MSc, Principal investigator, University Hospital of LarissaGeorge Tzovaras, MD, Study chair, University Hospital of LarissaGeorge Tzovaras, MD, Study director, University Hospital of LarissaStavroula Georgopoulou, MD, Study director, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520857
- Sponsor's protocol ID
- UTH5535/12/11
- Status last verified
- Mar 2017
- First submitted
- 19 Jan 2012
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia
- ClinicalTrials.gov ID
- NCT01520857
- Acronym / sponsor ID
- UTH5535/12/11
- Conditions
- Postoperative Pain
- Keywords
- Laparoscopic inguinal hernia repair, TAPP, Spinal Anesthesia, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- Oct 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Active comparator | Procedure: Transabdominal Preperitoneal repair of inguinal herniaTransabdominal Preperitoneal repair of inguinal hernia. spinal anesthesia |
| General Anesthesia | Active comparator | Procedure: Transabdominal Preperitoneal repair of inguinal herniaTransabdominal Preperitoneal repair of inguinal hernia. general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I-III
- BMI ≤ 35
- Age ≥ 18
- Normal coagulation profile
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transabdominal Preperitoneal repair of inguinal herniaTransabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia | Procedure or surgery | Spinal anesthesia |
| Transabdominal Preperitoneal repair of inguinal herniaTransabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia | Procedure or surgery | General Anesthesia |
Primary outcome
Postoperative opioid consumption
Time frame: Every 8 hours
The total dose of morphine was calculated as mg and administered by PCA pump
7 secondary outcomes
Postoperative pain
Time frame: Every 8 hrs
Side- effects
Time frame: Every 8 hrs
Hospital stay
Time frame: Patients will be followed for the duration of hospital stay
Patient satisfaction
Time frame: 2 weeks after the operation
Chronic Pain
Time frame: 12 months after the operation
Quality of life
Time frame: 6 months after the operation
Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chamaidi Sarakatsianou, RN,MSc principal investigator
University Hospital of Larissa
George Tzovaras, MD study chair
University Hospital of Larissa
George Tzovaras, MD study director
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal Preperitoneal repair of inguinal hernia in people with Postoperative Pain, run by Larissa University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: Every 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.