Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Liposomal Bupivacaine vs Ropivacaine for Post-hemorrhoidectomy Analgesia

26 augusti 2026 uppdaterad av: Liu Xiaona, Tongliao City People's Hospital

Liposomal Bupivacaine Versus Ropivacaine for Wound Infiltration Analgesia After Milligan-Morgan Open Hemorrhoidectomy: A Randomized Controlled Trial

This is a single-center, prospective, randomized, double-blind controlled trial comparing the analgesic efficacy, quality of recovery, and safety of perianal wound infiltration with multivesicular liposomal bupivacaine (266 mg) versus ropivacaine hydrochloride (200 mg) in patients undergoing Milligan-Morgan open hemorrhoidectomy under spinal anesthesia. Both solutions are diluted to a total volume of 30 mL and infiltrated at six predefined perianal positions at the end of surgery. The primary outcome is the resting visual analog scale (VAS) pain score at 24 hours after surgery. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative rescue analgesic consumption during postoperative days 1-3, Quality of Recovery-40 (QoR-40) scores on postoperative days 1-3, and adverse events within 72 hours after surgery.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Milligan-Morgan open hemorrhoidectomy is associated with substantial postoperative pain due to rich somatic innervation of the perianal region, wound exposure, anal sphincter spasm, and stimulation during defecation. Optimizing postoperative analgesia is critical for enhanced recovery. Local wound infiltration with ropivacaine is commonly used but provides limited duration of analgesia. Liposomal bupivacaine, formulated with a multivesicular liposomal delivery system, enables sustained release of bupivacaine at the injection site and may prolong local analgesia. However, high-quality comparative evidence between liposomal bupivacaine and ropivacaine for wound infiltration after open hemorrhoidectomy remains limited.

This single-center, prospective, randomized, double-blind controlled trial enrolled patients aged 18-60 years with grade III-IV internal hemorrhoids or mixed hemorrhoids scheduled for elective Milligan-Morgan open hemorrhoidectomy at Tongliao People's Hospital between November 2025 and May 2026. Patients were randomized 1:1 to receive perianal wound infiltration with either 266 mg of liposomal bupivacaine or 200 mg of ropivacaine hydrochloride, both diluted to 30 mL with normal saline and divided into six 5-mL aliquots infiltrated at six predefined perianal clock-face positions. All patients received spinal anesthesia with 15 mg of 0.5% hyperbaric bupivacaine. Rescue analgesia with oral diclofenac sodium 50 mg was provided when VAS pain score was ≥4.

The primary outcome is resting VAS pain score at 24 hours postoperatively. Secondary outcomes include resting and movement-evoked VAS pain scores at 4, 6, 12, 24, and 48 hours, cumulative diclofenac sodium consumption during postoperative days 1-3, QoR-40 total scores on postoperative days 1-3, and adverse events (nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, surgical-site infection) within 72 hours.

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
    • Tongliao
      • Neimeng, Tongliao, Kina, 028000
        • Tongliao People's Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 1. Aged 18-60 years, irrespective of sex 2. Diagnosed with grade III-IV internal hemorrhoids or mixed hemorrhoids based on specialist examination and scheduled to undergo elective Milligan-Morgan open hemorrhoidectomy 3. American Society of Anesthesiologists (ASA) physical status I-III 4. Body mass index (BMI) of 18.0-30.0 kg/m² 5. Able to understand and complete the pain and quality-of-recovery assessments and willing to participate in the study

Exclusion Criteria:

1. Concomitant chronic low back or leg pain, anal fissure, perianal abscess, or other persistent painful conditions 2. Pregnancy, breastfeeding, or plans to become pregnant in the near future 3. Known allergy to bupivacaine, ropivacaine, or any other medication used during the study 4. Long-term regular use of opioids or use of analgesic medications within 48 hours before surgery 5. Obstructive sleep apnea syndrome or severe cardiovascular, cerebrovascular, or pulmonary disease considered to significantly increase risks associated with neuraxial anesthesia or postoperative analgesia 6. Psychiatric or cognitive impairment that precludes completion of study assessments 7. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Liposomal Bupivacaine Group
Patients receive perianal wound infiltration with 266 mg of multivesicular liposomal bupivacaine (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
Läkemedel: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
266 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery
Aktiv komparator: Ropivacaine Group
Patients receive perianal wound infiltration with 200 mg of ropivacaine hydrochloride (20 mL) diluted with 10 mL normal saline to a total volume of 30 mL. The 30-mL solution is divided into six 5-mL aliquots and evenly infiltrated at six predefined perianal clock-face positions along the wound margins and adjacent tissues immediately after completion of surgery.
Läkemedel: Ropivacaine Hydrochloride
200 mg (20 mL) diluted with 10 mL normal saline to total 30 mL; infiltrated at six perianal positions at end of surgery

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Resting visual analog scale (VAS) pain score
Tidsram: 48 hours after surgery
Pain intensity at rest assessed using a 10-cm VAS, with 0 indicating no pain and 10 indicating the worst imaginable pain.
48 hours after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Resting and movement-evoked VAS pain scores
Tidsram: 4, 6, 12, 24, and 48 hours after surgery
Pain intensity at rest and during movement assessed using a 10-cm VAS at predefined postoperative time points.
4, 6, 12, 24, and 48 hours after surgery
Cumulative rescue analgesic consumption
Tidsram: Postoperative days 1-3 (within 72 hours)
Cumulative dose of oral diclofenac sodium (mg) consumed as rescue analgesia when VAS pain score ≥4. Maximum daily dose 150 mg, minimum interval 8 hours
Postoperative days 1-3 (within 72 hours)
Quality of Recovery-40 (QoR-40) total score
Tidsram: Postoperative days 1, 2, and 3
The QoR-40 comprises 40 items across five dimensions (physical comfort, emotional state, physical independence, psychological support, and pain). Total scores range from 40 to 200, with higher scores indicating better postoperative recovery.
Postoperative days 1, 2, and 3
Incidence of adverse events
Tidsram: Within 72 hours after surgery
Adverse events including nausea and vomiting, rash, lower-extremity numbness or weakness, local anesthetic systemic toxicity, perianal hematoma, and surgical-site infection
Within 72 hours after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tongliao City People's Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 augusti 2026

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

30 september 2027

Studieregistreringsdatum

Först inskickad

26 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

26 augusti 2026

Första postat (Faktisk)

31 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TongliaoCPH
  • 337087 (Registeridentifierare: China Clinical Trial Registration Center)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The datasets generated during this study are available from the corresponding author upon reasonable request by email.

Tidsram för IPD-delning

Following publication of the primary manuscript

Kriterier för IPD Sharing Access

Reasonable request by email to the corresponding author

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera