Örebro University Hospital
Örebro, 701 85, Sweden
NCT Number: NCT01492179
Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.
Looking for future studies?
Notify Me30 year–75 year
Female
Interventional
Phase 4
Örebro, 701 85, Sweden
Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.
Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal saline would be administered intravenously and intra-abdominally.
Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.
Other names: Xylocaine 5 mg/ml
Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h
Other names: Xylocaine 5 mg/ml
Time frame: 0 - 24 h postoperatively
Total rescue morphine consumption during 0 - 24 h would be the primary endpoint
Time frame: 4 h postoperatively
Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h
Time frame: 24 h
The plasma concentration of LA lidocaine would be analysed at 24 h in order to assess whether the LA absorption from the abdomen is similar to that administered intravenously.
Time frame: 1-5 days
The time to discharge home would be assessed using standardized criteria for home discharge.
Örebro University, Sweden
Other
A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.
Acronym: PoPuLAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02563392
Connective Tissue Diseases, Myofibroma
Geneva, Switzerland
View Trial DetailsNCT05086770
Connective Tissue Diseases, Leiomyoma
Seoul, South Korea
View Trial DetailsNCT05108597
Blood Loss, Surgical, Connective Tissue Diseases
Rawalpindi, Punjab Province, Pakistan
View Trial DetailsNCT04279626
Connective Tissue Diseases, Myofibroma
Taipei, Taiwan
View Trial Details