Postoperative PainNCT07051499
Effectiveness of TAP Block Versus Intravenous Analgesia in Postoperative Pain Management Following Gynecologic Laparoscopic Surgery
An observational study of Postoperative Pain, run by University of Foggia at 1 site in Italy.
Trial summary
Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TAP Block Group
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2025to 21 Jan 2026
- How long will I take part?
- 20 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery).
Who may be able to join
- age > 18 years, scheduled for elective gynecological surgery
Who cannot join
- age <18, emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of TAP Block Versus Intravenous Analgesia in Postoperative Pain Management Following Gynecological Laparoscopic Surgery
Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.
Read the detailed description
This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups:
- TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).
- Intravenous Analgesia Group: Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.
Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.
- Conditions
- Postoperative Pain
- Being tested
- TAP Block Group
- Keywords
- Gynecologic surgery, Pain management, TAP Block, Regional Anesthesia, Intravenous Analgesia, ERAS
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block GroupDrug
Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).
| Study group | Role | What they receive |
|---|---|---|
| tap block group | - TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron). | |
| intravenous analgesia | Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours. Receives: Drug: TAP Block Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (Numeric Rating Scale)
Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively.
Measured: 1, 6, 24 hours postoperatively.
Secondary outcomes (3)
Total Analgesic Consuption.
Total dose of tramadol (in Milligrams) administered in the first 24 hours after surgery will be recorded and compared between groups.
Measured: 0-24 hours postoperatively.
Incidence of Side Effects.
Occurrence of side effects such nausea, vomiting and sedation will be recorded and expressed as a percentage of patients (%) affected in each group.
Measured: 0-24 hours postoperatively
Patient Satisfaction With Analgesia
Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale (1= very dissatisfied; 5= very satisfied) at 24 hours after surgery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start21 Jan 2025
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Jan 2026 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michela Rauseo, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051499
- Sponsor's protocol ID
- TAP BLOCK GYNECOLOGIC SURGERY
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not sure
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TAP Block Versus Intravenous Analgesia in Postoperative Pain Management Following Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07051499
- Acronym / sponsor ID
- TAP BLOCK GYNECOLOGIC SURGERY
- Conditions
- Postoperative Pain
- Keywords
- Gynecologic surgery, Pain management, TAP Block, Regional Anesthesia, Intravenous Analgesia, ERAS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- 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.
Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.
Detailed description
This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups:
- TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).
- Intravenous Analgesia Group: Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.
Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tap block group | – | –- TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron). |
| intravenous analgesia | – | Drug: TAP Block GroupStandard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery).
Key inclusion criteria (1 listed)
- age > 18 years, scheduled for elective gynecological surgery
Key exclusion criteria (1 listed)
- age <18, emergency surgery
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 |
|---|---|---|
| TAP Block GroupBilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron). | Drug | intravenous analgesia |
Primary outcome
Postoperative pain intensity (Numeric Rating Scale)
Time frame: 1, 6, 24 hours postoperatively.
Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively.
3 secondary outcomes
Total Analgesic Consuption.
Time frame: 0-24 hours postoperatively.
Incidence of Side Effects.
Time frame: 0-24 hours postoperatively
Patient Satisfaction With Analgesia
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Undecided. Not sure
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by University of Foggia at 1 site in Italy.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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 pain intensity (Numeric Rating Scale) (time frame: 1, 6, 24 hours postoperatively.). 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 4 Jul 2025.