Pain management after immediate implant placement

Application of liposomal bupivacaine in pain management after immediate implant placement

Registry ID
ISRCTN90549666
Source registry
ISRCTN
Status
No longer recruiting
Phase
PHASE4
Study type
INTERVENTIONAL
Sponsor
Changshu Yuhui Dental Hospital
Enrollment
26
Start date
2025-09-01
Completion date
2026-02-28
Last update
2026-08-17

Conditions

Summary

Postoperative pain management in patients undergoing immediate dental implant placement (≤3 implants)

Detailed description

Participants were randomly assigned to an experimental group (n=16) and a control group (n=16) using a random number table. The specific steps for randomization and allocation concealment were as follows: 1. Random Sequence Generation: A research assistant (not involved in clinical procedures or evaluations) generated a random number sequence for patients numbered 1~32 using SPSS 22.0 software; 2. Allocation Concealment: Based on the random allocation sequence, group information (the experimental group or control group) was placed into sequentially numbered, sealed, and opaque envelopes (SNOSE method). These envelopes were kept by designated personnel to ensure that the clinical physicians, evaluators, and patients could not access group information before patient enrollment and signing of informed consent forms; 3. Implementation of Randomization: After enrollment, patients were numbered in the order of their inclusion. A surgical assistant sequentially opened the corresponding numbered envelope, assigned the patients to the experimental or control group following the instructions inside the envelope, and then notified the operating physician to execute the corresponding analgesic protocol. Experimental group: Routine articaine anaesthesia was implemented. After surgery, 3–5 ml of 1.3% liposomal bupivacaine was injected subperiosteally and around incisions: 3 ml for a single implant, 4–5 ml for 2–3 implants, with local compression for 1–2 min after injection. Control group: Only routine articaine anaesthesia was used without postoperative long-acting local anaesthetic. Surgical procedures were identical in the two groups.

Interventions

Inclusion criteria

1. ≤3 immediate implants with intact socket bone wall 2. Aged 18–70 years, American Society of Anesthesiologists (ASA) I–II 3. No local anaesthetic or nonsteroidal anti-inflammatory drug (NSAID) allergy 4. Complete 72-h follow-up 5. Voluntary informed consent

Exclusion criteria

1. Women who are pregnant or lactating 2. Severe cardiopulmonary, hepatic or renal disease, coagulation disorders or uncontrolled diabetes (fasting blood glucose >8.0 mmol/l) 3. Combined bone grafting and sinus elevation 4. Long-term analgesic or hormone dependence 5. Patients with psychiatric disorders who are unable to cooperate 6. Acute or chronic inflammation of the surgical site

Locations

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