NCT07116564

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
6mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Aug 2025Nov 2026

First Submitted

Initial submission to the registry

July 24, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

July 24, 2025

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

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.

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

Secondary Outcomes (3)

  • Postoperative pain score

    4 hours, 8 hours, 12 hours, 24 hours, 48 hours & 72 hours postoperatively

  • Amount of opioid used in patient controlled analgesia

    12 hours postoperatively.

  • Patient satisfaction Score

    24 hours after the operation

Study Arms (2)

Group C

ACTIVE COMPARATOR
Drug: Control

Group E

EXPERIMENTAL
Drug: Enhanced Recovery After Surgery

Interventions

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.

Group E

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

Group C

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I, II, and III
  • Patients scheduled for elective laparoscopic gynecological surgeries

You may not qualify if:

  • Refusal to participate
  • History of allergy or contraindication to study drugs
  • Patients in which procedure converted to open surgery
  • Diagnostic laparoscopic procedures
  • Patients with a history of severe anxiety or depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University, Karachi, Pakistan

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Central Study Contacts

Ali Sarfraz Siddiqui, MBBS, MCPS, FCPS, FIPP, MHPE

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 11, 2025

Study Start

August 20, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations