An Early Phase 1 interventional study of Marcaine 0.5 % Injectable Solution and Sodium Chloride 0.9% in Pain, Postoperative, sponsored by Wolfson Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Wolfson Medical Center · Early Phase 1, Interventional, and Supportive care
Among 362 studies testing bupivacaine in Pain, Postoperative — 55 open to participants now, 58 under way, 5 of them phase 3. Bupivacaine · Pain, Postoperative.
Among the 362 studies testing bupivacaine in Pain, Postoperative, this one is the 203rd largest by enrollment, is one of 31 that started in 2017, is one of 21 in phase 1, and was the 126th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →55 of the 362 studies testing bupivacaine in Pain, Postoperative are open now, in 8 countries. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →362 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 31 started in 2017.
Median enrollment 70 across the 362 interventional studies. Of the 258 that completed or were terminated, 106 (41%) have results posted.
46 of 362 have an industry lead sponsor. The 10 most frequent:
Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Wolfson Medical Center has 2 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
21 of the studies testing bupivacaine in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06350981Phase 3Foundation for Orthopaedic Research and EducationAnalgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion | 2027-01-01 |
| NCT06077422Phase 3Rutgers, The State University of New JerseyExparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain | 2027-01-11 |
| NCT07650760Wah Medical college , POF hospitalComparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy | 2026-12 |
| NCT03737292Milton S. Hershey Medical CenterLiposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy | 2026-12 |
| NCT02381353Mayo ClinicExparel Injection for Postoperative Orbital Pain | 2026-12 |
Among the 362 studies testing bupivacaine in Pain, Postoperative, from their registry updates:
The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.
This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line.
By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
additional abdominal, chronic pelvic pain, , and allergy to Bupivacaine.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Marcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.
Drug: Marcaine 0.5 % Injectable Solution
Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.
Drug: Sodium Chloride 0.9%
Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
Also known as: Study
Local infiltration by Sodium Chloride 0.9% prior to incision
Also known as: Placebo
Pain at movement
Movement-evoked pain will be scored after the operation
Time frame: 24 hours
pain at rest
Pain at rest will be scored with the woman lying in bed after the operation
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine