Clinical trial · Interventional
Postoperative Analgesic Efficacy of Continuous Wound Infusion After Laparoscopy
Postoperative Analgesic Efficacy of Continuous Wound Infusion With Local Anesthetics After Laparoscopy (PAIN): a Randomized, Double-blind, Placebo-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Studies evaluating the effectiveness of continuous wound infusion (CWI) to manage postoperative pain following laparoscopy are markedly lacking. Especially, there was no study comparing CWI and placebo in treating gynecologic laparoscopy. Therefore, the investigators conducted this randomized, double-blind, placebo-controlled trial to investigate whether CWI of local anesthetics was an effective strategy for enhanced recovery after surgery (ERAS), compared with placebo in patients undergoing benign gynecologic laparoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Gynecologic Neoplasm | Benign Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% saline group | Drug | — | UNRESOLVED |
| ON-Q Painbuster Silver Soaker | Device | — | UNRESOLVED |
| Ropivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ropivacaine group
- description
- Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine .
- interventionNames
- Drug: Ropivacaine
- Device: ON-Q Painbuster Silver Soaker
- type
- PLACEBO_COMPARATOR
- label
- 0.9% Saline group
- description
- Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the control group, an elastomeric pump filled with filled with 100ml of 0.9% saline .
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 80 years, * American Society of Anesthesiologists physical status (ASAPS) classification I-II * the absence of pregnancy at the time of surgery Exclusion Criteria: * allergy to amide local anesthetics including ropivacaine * laparoscopic surgery needing ≥ 3 separate skin incisions * history of ventral or incisional hernia * pre-existing coagulopathy, neurologic or cognitive dysfunction * systemic or regional (especially, umbilicus) infection * previously taking opioids for acute or chronic pain * inability to accurately express their pain.
References
Publications (0)
Data not yet available