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NCT06243263
Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery
Phase 4 trial testing Bupivacain in Postoperative Pain in 30 participants. Status unknown.
4 March 2024
Quick facts
| Lead sponsor | University Tunis El Manar |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 6 February 2024 |
| Primary completion | 4 March 2024 |
| Estimated completion | 4 March 2024 |
| Sites | 2 locations across Tunisia |
Drugs / interventions tested
- Bupivacain — full drug profile →
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Mandible Fracture — all drugs for Mandible Fracture →
- Analgesia — all drugs for Analgesia →
- Anesthesia, Local — all drugs for Anesthesia, Local →
Sponsor
University Tunis El Manar
Who can join
Adults 18 to 60, any sex, with Postoperative Pain or Mandible Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures. The main question it aims to answer are: * Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery? * Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours? Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block. The patient: * Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture. * They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted. Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06243263
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Other University Tunis El Manar trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06243263 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Tunis El Manar
- Last refreshed: 14 February 2024
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