Postoperative PainbupivacaineNCT07435909
Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy
A study testing Bupivacaine %0.5 (hyperbaric) in people with Postoperative Pain, run by Serkan Kumbasar at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, single-blind controlled study aims to evaluate the effect of bupivacaine injection at trocar entry sites and the vaginal cuff on postoperative pain in patients undergoing total laparoscopic hysterectomy for benign gynecologic conditions. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine %0.5 (hyperbaric)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 4 Jun 2026
- Phase
- Interventional
- 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 35-75 years
- Scheduled for total laparoscopic hysterectomy for benign gynecologic conditions, including leiomyoma uteri, adenomyosis, abnormal uterine bleeding, endometrial pathology (non-atypical hyperplasia, endometrial thickening, or polyps), cervical intraepithelial lesions (CIN 2-3) without evidence of invasion and indicated for therapeutic hysterectomy, chronic pelvic pain, or benign uterine prolapse
- American Society of Anesthesiologists (ASA) physical status class I-II
- Cognitive ability sufficient to assess and report postoperative pain (no dementia or severe psychiatric disorder)
- Provision of written informed consent
- Completion of surgery laparoscopically as planned (no conversion to laparotomy)
Who cannot join
- Presence or suspicion of malignant gynecologic disease
- History of allergy or hypersensitivity to bupivacaine or other amide-type local anesthetics
- History of chronic pain syndrome, analgesic dependence, or regular use of opioids or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Severe systemic disease (e.g., uncontrolled diabetes mellitus, hepatic or renal insufficiency, or heart failure)
- Neurological or psychiatric disorders that impair the ability to assess or report pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBÜ Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa
About this study
Official title: Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy
This prospective, randomized, single-blind controlled study aims to evaluate the effect of bupivacaine injection at trocar entry sites and the vaginal cuff on postoperative pain in patients undergoing total laparoscopic hysterectomy for benign gynecologic conditions.
Postoperative pain after laparoscopic hysterectomy may arise from trocar insertion sites and surgical manipulation of the vaginal cuff. Local anesthetic infiltration may reduce somatic pain and improve early recovery.
Read more
Eligible patients will be randomly assigned to either receive 0.5% bupivacaine injection at trocar sites and the vaginal cuff at the end of surgery or receive no local anesthetic injection (control group). All patients will receive standard postoperative analgesia.
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours after surgery. Secondary outcomes include additional analgesic requirement, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications.
Read the detailed description
Total laparoscopic hysterectomy (TLH) is widely performed for benign gynecologic conditions and is associated with shorter hospital stay and faster recovery compared with open surgery. However, postoperative pain remains a relevant clinical concern. Pain after TLH may originate from abdominal trocar entry sites as well as surgical manipulation and suturing of the vaginal cuff.
Local anesthetic infiltration is a component of multimodal analgesia strategies aimed at reducing postoperative pain and opioid consumption. Bupivacaine, a long-acting amide-type local anesthetic, has been used for surgical wound infiltration with variable results. While previous studies have evaluated trocar site infiltration alone, limited data are available regarding the combined infiltration of both trocar sites and the vaginal cuff in patients undergoing TLH.
This study is designed as a prospective, randomized, single-blind controlled trial conducted at a tertiary referral center. Eligible patients undergoing TLH for benign indications will be randomized into two groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff (a total of 2 ml into both sacrouterin ligaments). After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive local anesthetic infiltration. All surgical procedures will be performed using a standardized TLH technique by the same surgical team.
Pain intensity will be assessed using repeated measurements over the first 24 postoperative hours. The study will also evaluate recovery-related parameters and safety outcomes. Statistical analysis will be performed using mixed-effects modeling to account for repeated pain measurements over time, with a two-sided significance level of 0.05.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine %0.5 (hyperbaric)
- Keywords
- bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine %0.5 (hyperbaric)Drug
Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 1 mL bilaterally to the vaginal cuff (total 2 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Bupivacaine Group) | Experimental | Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL solution will be administered: 5 mL to the 10 mm trocar site and 5 mL distributed among the three 5 mm trocar sites. In addition, bupivacaine will be injected into the vaginal cuff region prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized. Receives: Drug: Bupivacaine %0.5 (hyperbaric) |
| Control Group | No intervention | Participants undergoing total laparoscopic hysterectomy will not receive local anesthetic infiltration at the trocar sites or vaginal cuff. All other surgical procedures and postoperative analgesia protocols will be identical to those of the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.
Measured: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 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 posted27 Feb 2026
- Study start28 Aug 2025
- Primary completion4 Jun 2026 (estimated)
- Study completion4 Jun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL of normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff. After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive any local anesthetic infiltration. Outcomes will be compared between groups during the first 24 postoperative hours, and no crossover between groups will occur.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serkan Kumbasar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Serkan Kumbasar, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435909
- Sponsor's protocol ID
- bupivacaine-tlh
- Acronym
- bupivacaine
- Status last verified
- May 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07435909
- Acronym / sponsor ID
- bupivacaine / bupivacaine-tlh
- Conditions
- Postoperative Pain
- Keywords
- bupivacaine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Serkan KumbasarOther government
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 4 Jun 2026 (estimated)
- Study completion
- 4 Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (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 prospective, randomized, single-blind controlled study aims to evaluate the effect of bupivacaine injection at trocar entry sites and the vaginal cuff on postoperative pain in patients undergoing total laparoscopic hysterectomy for benign gynecologic conditions.
Postoperative pain after laparoscopic hysterectomy may arise from trocar insertion sites and surgical manipulation of the vaginal cuff. Local anesthetic infiltration may reduce somatic pain and improve early recovery.
Eligible patients will be randomly assigned to either receive 0.5% bupivacaine injection at trocar sites and the vaginal cuff at the end of surgery or receive no local anesthetic injection (control group). All patients will receive standard postoperative analgesia.
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours after surgery. Secondary outcomes include additional analgesic requirement, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications.
Detailed description
Total laparoscopic hysterectomy (TLH) is widely performed for benign gynecologic conditions and is associated with shorter hospital stay and faster recovery compared with open surgery. However, postoperative pain remains a relevant clinical concern. Pain after TLH may originate from abdominal trocar entry sites as well as surgical manipulation and suturing of the vaginal cuff.
Local anesthetic infiltration is a component of multimodal analgesia strategies aimed at reducing postoperative pain and opioid consumption. Bupivacaine, a long-acting amide-type local anesthetic, has been used for surgical wound infiltration with variable results. While previous studies have evaluated trocar site infiltration alone, limited data are available regarding the combined infiltration of both trocar sites and the vaginal cuff in patients undergoing TLH.
This study is designed as a prospective, randomized, single-blind controlled trial conducted at a tertiary referral center. Eligible patients undergoing TLH for benign indications will be randomized into two groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff (a total of 2 ml into both sacrouterin ligaments). After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive local anesthetic infiltration. All surgical procedures will be performed using a standardized TLH technique by the same surgical team.
Pain intensity will be assessed using repeated measurements over the first 24 postoperative hours. The study will also evaluate recovery-related parameters and safety outcomes. Statistical analysis will be performed using mixed-effects modeling to account for repeated pain measurements over time, with a two-sided significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL of normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff. After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive any local anesthetic infiltration. Outcomes will be compared between groups during the first 24 postoperative hours, and no crossover between groups will occur.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Bupivacaine Group) | Experimental | Drug: Bupivacaine %0.5 (hyperbaric)Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL solution will be administered: 5 mL to the 10 mm trocar site and 5 mL distributed among the three 5 mm trocar sites. In addition, bupivacaine will be injected into the vaginal cuff region prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized. |
| Control Group | No intervention | –Participants undergoing total laparoscopic hysterectomy will not receive local anesthetic infiltration at the trocar sites or vaginal cuff. All other surgical procedures and postoperative analgesia protocols will be identical to those of the intervention group. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients aged 35-75 years
- Scheduled for total laparoscopic hysterectomy for benign gynecologic conditions, including leiomyoma uteri, adenomyosis, abnormal uterine bleeding, endometrial pathology (non-atypical hyperplasia, endometrial thickening, or polyps), cervical intraepithelial lesions (CIN 2-3) without evidence of invasion and indicated for therapeutic hysterectomy, chronic pelvic pain, or benign uterine prolapse
- American Society of Anesthesiologists (ASA) physical status class I-II
- Cognitive ability sufficient to assess and report postoperative pain (no dementia or severe psychiatric disorder)
- Provision of written informed consent
Key exclusion criteria (5 listed)
- Presence or suspicion of malignant gynecologic disease
- History of allergy or hypersensitivity to bupivacaine or other amide-type local anesthetics
- History of chronic pain syndrome, analgesic dependence, or regular use of opioids or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Severe systemic disease (e.g., uncontrolled diabetes mellitus, hepatic or renal insufficiency, or heart failure)
- Neurological or psychiatric disorders that impair the ability to assess or report pain
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 %0.5 (hyperbaric)Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 1 mL bilaterally to the vaginal cuff (total 2 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized. | Drug | Intervention Group (Bupivacaine Group) |
Primary outcome
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 24 hours postoperatively)
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.
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 27 May 2026.
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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.
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 %0.5 (hyperbaric) in people with Postoperative Pain, run by Serkan Kumbasar 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?
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?
Contact serkan kumbasar, md (5067873216, drserkankumbasar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 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 27 May 2026.