Pre-incisional Infiltration With Ropivacaine Plus Diprospan for Relieving Postoperative Pain After Laparoscopic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

About this trial

Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery, but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.

Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. Preemptive incisional infiltration using local anesthetics with corticosteroids which have potent local anti-inflammatory properties may play a key role in preventing or reducing postoperative pain. The objective of this trial is to determine whether preemptive incisional infiltration with ropivacaine plus diprospan is superior to ropivacaine alone in relieving postoperative pain for adults undergoing laparoscopic surgery. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;

Ages 18 to 64 years old;

American Society of Anesthesiologists (ASA) physical status of I-III;

Patients must be able to understand nature and potential personal; consequences of the clinical trial and cooperation with follow-up investigations;

Disqualifiers

History of allergies to experimental drugs such as opioids or steroids;

Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics;

Use analgesic drugs within 24 hours before surgery;

Patients undergoing steroid therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre-incisional infiltration with ropivacaine and diprospan

    Drug

    Before the surgery, according to the surgeon's incision marking, the patients accept 0.5ml of diprospan (1ml diprospan: Betamethasone Dipropionate 5mg and Betamethasone Sodium Phosphate 2mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).

  • Pre-incisional infiltration with ropivacaine alone

    Drug

    Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Pre-incisional infiltration with ropivacaine plus diprospanExperimental treatment 1 intervention
Group B: Pre-incisional infiltration with ropivacaine aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame
The postoperative period 48 hours

Secondary outcomes

1

Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

Description: scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain

Time frame
Data will be collected at 4、12、24、36 and 72 hours postoperatively
2

Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Data will be collected at 4、12、24、36 and 72 hours postoperatively
3

Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Postoperative day 7, month 1, and month 3.
4

Patient Satisfaction Scale(PSS)

Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".

Time frame
Postoperative hours 4、12、24 and 48 hours

Other outcomes

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