An interventional study of Bupivacaine %0.5 (hyperbaric) in Postoperative Pain, sponsored by Serkan Kumbasar. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Serkan Kumbasar · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Serkan Kumbasar as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Bupivacaine %0.5 (hyperbaric)
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.
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.
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.
Time frame: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 24 hours postoperatively)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.