Inguinal Hernia Repair (Not Urgent)DEXA-BUPINCT07208253
Dexamethasone and Bupivacaine for Pain After Hernia Surgery
A study testing Bupivacaine + Dexamethasone in people with Inguinal Hernia Repair (Not Urgent), run by Gürkan Değirmencioğlu at 1 site in Turkey (Türkiye).
Trial summary
This study looked at whether a combination of two medicines, dexamethasone and bupivacaine, can reduce pain after laparoscopic hernia surgery. A total of 175 patients who had elective total extraperitoneal (TEP) hernia repair were randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Repair (Not Urgent)
- What is being tested?
- Bupivacaine + Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 15 Jan 2023
- 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
- Adults (≥18 years old) scheduled for elective unilateral inguinal hernia repair with the laparoscopic total extraperitoneal (TEP) technique
- American Society of Anesthesiologists (ASA) physical status I-II
- Ability to provide informed consent
Who cannot join
- Age <18 years
- ASA physical status ≥III
- Recurrent or bilateral inguinal hernia
- History of allergy to local anesthetics or corticosteroids
- Chronic opioid use or dependence
- Severe hepatic, renal, or cardiac disease
- Pregnancy or breastfeeding
- Patients who declined to participate or could not provide consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital (Etlik Şehir Hastanesi)
Ankara, Ankara, 06010
About this study
Official title: Effect of Dexamethasone and Bupivacaine on Postoperative Pain Following Total Extraperitoneal Hernioplasty: A Randomized Controlled Prospective Study
This study looked at whether a combination of two medicines, dexamethasone and bupivacaine, can reduce pain after laparoscopic hernia surgery. A total of 175 patients who had elective total extraperitoneal (TEP) hernia repair were randomly assigned to two groups. One group received a spray of dexamethasone and bupivacaine around the surgical mesh, while the other group did not receive any local treatment.
Pain levels were measured at 3, 6, and 12 hours after surgery using a visual pain scale. The need for additional pain medicine and patient satisfaction were also recorded. Patients who received dexamethasone and bupivacaine reported lower pain scores, needed less extra pain medicine, and were more satisfied with their pain control compared to the control group.
The results suggest that this simple, safe, and low-cost method may help improve pain control and comfort after laparoscopic hernia repair.
Read the detailed description
This randomized controlled study investigated the effect of adding dexamethasone to bupivacaine for pain management after laparoscopic total extraperitoneal (TEP) hernia repair. Postoperative pain is still a significant concern after TEP, even though this minimally invasive technique generally causes less pain than open surgery. Local anesthetics such as bupivacaine are widely used, but their effect is limited in duration. Dexamethasone, an anti-inflammatory corticosteroid, has been shown to enhance and prolong analgesia when combined with local anesthetics.
A total of 175 patients undergoing elective unilateral TEP hernioplasty were randomized into two groups. The intervention group received 20 mg of bupivacaine (4 mL of 0.5%) mixed with 8 mg dexamethasone, sprayed directly on the surgical mesh and surrounding tissues after mesh placement. The control group did not receive any local treatment in the operative field. All patients received standard postoperative analgesia.
Pain scores were assessed using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery. The need for additional analgesics, patient satisfaction, and early complications were also recorded.
Results showed that patients in the dexamethasone + bupivacaine group had significantly lower pain scores at all time points, required fewer additional analgesics, and reported higher satisfaction compared to controls. No increase in surgical complications was observed.
This study suggests that the local application of dexamethasone combined with bupivacaine is a safe, simple, and cost-effective method to improve early postoperative pain control and patient comfort after laparoscopic TEP hernia repair.
- Conditions
- Inguinal Hernia Repair (Not Urgent)
- Being tested
- Bupivacaine + Dexamethasone
- Keywords
- Inguinal Hernia, Total Extraperitoneal Hernioplasty (TEP), Postoperative Pain, Dexamethasone, Bupivacaine, Randomized Controlled Trial
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + DexamethasoneDrug
20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone, sprayed locally over the mesh and surrounding tissues after placement during laparoscopic TEP hernioplasty.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | Patients received 20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone. The solution was sprayed over the mesh and surrounding tissues after mesh placement during laparoscopic total extraperitoneal (TEP) hernioplasty. Receives: Drug: Bupivacaine + Dexamethasone |
| No Intervention: Control Group | No intervention | Patients underwent standard laparoscopic total extraperitoneal (TEP) hernioplasty without local application of bupivacaine or dexamethasone in the operative field. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Pain intensity measured using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery.
Measured: 12 hours after surgery
Secondary outcomes (3)
Additional Analgesic Requirement
Number of patients requiring supplemental analgesics during the first 24 hours after surgery.
Measured: 24 hours after surgery
Patient Satisfaction
Patient-reported satisfaction with pain management, scored on a 4-point Likert scale (poor, moderate, good, excellent).
Measured: Within 24 hours after surgery
Postoperative Complications
Frequency of early complications such as hematoma, urinary retention, wound infection.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia Repair (Not Urgent)Studies 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
- Model description
- Randomized, two-arm, parallel assignment study comparing dexamethasone plus bupivacaine versus no local treatment in patients undergoing elective unilateral laparoscopic total extraperitoneal (TEP) hernioplasty.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gürkan Değirmencioğlu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gürkan Değirmencioğlu, Ankara Etlik City Hospital
- Investigators
- GÜRKAN DEĞİRMENCİOĞLU, MD, Principal investigator, Etlik City Hospital, Department of General Surgery, Ankara,Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208253
- Sponsor's protocol ID
- EŞH-GC-2025-01
- Other IDs
- 2021/26
- Acronym
- DEXA-BUPI
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because this was a single-center study with a limited sample size, and data sharing is not planned in the study protocol.
Publications
Degirmencioglu G, Kutuk D, Canakci MH. Effect of topical dexamethasone and bupivacaine application on postoperative pain following total extraperitoneal hernioplasty: a randomized controlled prospective study. BMC Surg. 2026 Feb 24;26(1):234. doi: 10.1186/s12893-026-03627-3.
PubMed 41731439
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone and Bupivacaine on Postoperative Pain Following Total Extraperitoneal Hernioplasty: A Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT07208253
- Acronym / sponsor ID
- DEXA-BUPI / EŞH-GC-2025-01
- Conditions
- Inguinal Hernia Repair (Not Urgent)
- Keywords
- Inguinal Hernia, Total Extraperitoneal Hernioplasty (TEP), Postoperative Pain, Dexamethasone, Bupivacaine, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Gürkan DeğirmencioğluOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 6 Oct 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.
This study looked at whether a combination of two medicines, dexamethasone and bupivacaine, can reduce pain after laparoscopic hernia surgery. A total of 175 patients who had elective total extraperitoneal (TEP) hernia repair were randomly assigned to two groups. One group received a spray of dexamethasone and bupivacaine around the surgical mesh, while the other group did not receive any local treatment.
Pain levels were measured at 3, 6, and 12 hours after surgery using a visual pain scale. The need for additional pain medicine and patient satisfaction were also recorded. Patients who received dexamethasone and bupivacaine reported lower pain scores, needed less extra pain medicine, and were more satisfied with their pain control compared to the control group.
The results suggest that this simple, safe, and low-cost method may help improve pain control and comfort after laparoscopic hernia repair.
Detailed description
This randomized controlled study investigated the effect of adding dexamethasone to bupivacaine for pain management after laparoscopic total extraperitoneal (TEP) hernia repair. Postoperative pain is still a significant concern after TEP, even though this minimally invasive technique generally causes less pain than open surgery. Local anesthetics such as bupivacaine are widely used, but their effect is limited in duration. Dexamethasone, an anti-inflammatory corticosteroid, has been shown to enhance and prolong analgesia when combined with local anesthetics.
A total of 175 patients undergoing elective unilateral TEP hernioplasty were randomized into two groups. The intervention group received 20 mg of bupivacaine (4 mL of 0.5%) mixed with 8 mg dexamethasone, sprayed directly on the surgical mesh and surrounding tissues after mesh placement. The control group did not receive any local treatment in the operative field. All patients received standard postoperative analgesia.
Pain scores were assessed using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery. The need for additional analgesics, patient satisfaction, and early complications were also recorded.
Results showed that patients in the dexamethasone + bupivacaine group had significantly lower pain scores at all time points, required fewer additional analgesics, and reported higher satisfaction compared to controls. No increase in surgical complications was observed.
This study suggests that the local application of dexamethasone combined with bupivacaine is a safe, simple, and cost-effective method to improve early postoperative pain control and patient comfort after laparoscopic TEP hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, two-arm, parallel assignment study comparing dexamethasone plus bupivacaine versus no local treatment in patients undergoing elective unilateral laparoscopic total extraperitoneal (TEP) hernioplasty.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Drug: Bupivacaine + DexamethasonePatients received 20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone. The solution was sprayed over the mesh and surrounding tissues after mesh placement during laparoscopic total extraperitoneal (TEP) hernioplasty. |
| No Intervention: Control Group | No intervention | –Patients underwent standard laparoscopic total extraperitoneal (TEP) hernioplasty without local application of bupivacaine or dexamethasone in the operative field. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years old) scheduled for elective unilateral inguinal hernia repair with the laparoscopic total extraperitoneal (TEP) technique
- American Society of Anesthesiologists (ASA) physical status I-II
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Age <18 years
- ASA physical status ≥III
- Recurrent or bilateral inguinal hernia
- History of allergy to local anesthetics or corticosteroids
- Chronic opioid use or dependence
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 |
|---|---|---|
| Bupivacaine + Dexamethasone20 mg bupivacaine (4 mL of 0.5%) combined with 8 mg dexamethasone, sprayed locally over the mesh and surrounding tissues after placement during laparoscopic TEP hernioplasty. | Drug | Experimental: Intervention Group |
Primary outcome
Postoperative Pain Scores
Time frame: 12 hours after surgery
Pain intensity measured using the Visual Analog Scale (VAS) at 3, 6, and 12 hours after surgery.
3 secondary outcomes
Additional Analgesic Requirement
Time frame: 24 hours after surgery
Patient Satisfaction
Time frame: Within 24 hours after surgery
Postoperative Complications
Time frame: Within 30 days after surgery
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 6 Oct 2025.
- Derived from this study: PubMed 41731439Degirmencioglu G, Kutuk D, Canakci MH. Effect of topical dexamethasone and bupivacaine application on postoperative pain following total extraperitoneal hernioplasty: a randomized controlled prospective study. BMC Surg. 2026 Feb 24;26(1):234. doi: 10.1186/s12893-026-03627-3.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because this was a single-center study with a limited sample size, and data sharing is not planned in the study protocol.
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.
GÜRKAN DEĞİRMENCİOĞLU, MD principal investigator
Etlik City Hospital, Department of General Surgery, Ankara,Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine + Dexamethasone in people with Inguinal Hernia Repair (Not Urgent), run by Gürkan Değirmencioğlu at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 6 Oct 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 Turkey (Türkiye). 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 Pain Scores (time frame: 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208253, which also lists 1 linked publication.
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 6 Oct 2025.