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Impact of ERAS Protocol on Length of Hospital Stay After Laparoscopic Surgeries

ConditionERAS
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-60
SponsorAga Khan University

About this trial

The goal of this clinical trial is to determine the length of hospital stay in patients using multimodal analgesia with or without ERAS protocol scheduled for elective laparoscopic gynecological surgeries

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status I, II, and III

Patients scheduled for elective laparoscopic gynecological surgeries

Disqualifiers

Refusal to participate

History of allergy or contraindication to study drugs

Patients in which procedure converted to open surgery

Diagnostic laparoscopic procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Recovery After Surgery

    Drug

    Preoperatively ERAS protocol includes, No solid food for 6 hours before procedure; 800 ml (fantomalt powder) Carbohydrate drink 8 hours before surgery; 400 ml (fantomalt powder) 2 hours before surgery; Celecoxib 200g 1 hour before surgery . Intraoperatively, on induction lidocaine 1.5 mg/kg and Fentanyl 1 to 2 mcg/kg followed by IV lidocaine infusion at 1.5 mg/kg/h.

  • Control

    Drug

    Preoperatively, NPO 6 hours before the procedure Intraoperatively, on induction Nabuphine 0.1mg/kg

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Group CActive comparator 1 intervention
Group B: Group EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

Post-operative length of hospital stay, measured in hours from the patient's arrival in the recovery room until 72 hours after surgery.

Time frame
From arrival in the recovery room post-surgery until 72 hours after surgery.

Secondary outcomes

1

Postoperative pain score

Post operative pain score will be measures using NRS (Numerical Rating Scale). Eleven points pain scale measures from 0-10, where "0" is no pain and "10" is the worst possible pain

Time frame
4 hours, 8 hours, 12 hours, 24 hours, 48 hours & 72 hours postoperatively
2

Amount of opioid used in patient controlled analgesia

Total Nalbuphine consumption in 12 hours (in milligrams)

Time frame
12 hours postoperatively.
3

Patient satisfaction Score

Patient satisfaction with the pain management regimen will be assessed using a five-point Likert scale 24 hours after surgery. The scale ranges from 1 to 5, where 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, and 5 = Very Satisfied. Higher scores indicate greater satisfaction.

Time frame
24 hours after the operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Source ClinicalTrials.gov
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