ERASPhase 4NCT07116564
Impact of ERAS Protocol on Length of Hospital Stay After Laparoscopic Surgeries
A Phase 4 study testing Enhanced Recovery After Surgery in people with ERAS, run by Aga Khan University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- ERAS
- What is being tested?
- Enhanced Recovery After Surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2025to 1 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I, II, and III
- Patients scheduled for elective laparoscopic gynecological surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali Sarfraz Siddiqui, MBBS, MCPS, FCPS, FIPP, MHPE contact
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University, Karachi, Pakistan
Karachi, Sindh
Ali Sarfraz Siddiqui, FCPS, MHPE, 009234864397 ext. 4397, sarfraz.siddiqui@aku.edu
About this study
Official title: Impact of Multimodal Analgesia and ERAS Protocol on Length of Hospital Stay After Laparoscopic Gynecological Surgeries: A Randomized Control 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
- Conditions
- ERAS
- Being tested
- Enhanced Recovery After Surgery, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After SurgeryDrug
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.
ControlDrug
Preoperatively, NPO 6 hours before the procedure Intraoperatively, on induction Nabuphine 0.1mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Not described Receives: Drug: Control |
| Group E | Experimental | Not described Receives: Drug: Enhanced Recovery After Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From arrival in the recovery room post-surgery until 72 hours after surgery.
Secondary outcomes (3)
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
Measured: 4 hours, 8 hours, 12 hours, 24 hours, 48 hours & 72 hours postoperatively
Amount of opioid used in patient controlled analgesia
Total Nalbuphine consumption in 12 hours (in milligrams)
Measured: 12 hours postoperatively.
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.
Measured: 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start20 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Sarfraz Siddiqui, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116564
- Sponsor's protocol ID
- 2025-11268-35403
- Other IDs
- 2025
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multimodal Analgesia and ERAS Protocol on Length of Hospital Stay After Laparoscopic Gynecological Surgeries: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07116564
- Acronym / sponsor ID
- 2025-11268-35403
- Conditions
- ERAS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: Control |
| Group E | Experimental | Drug: Enhanced Recovery After Surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I, II, and III
- Patients scheduled for elective laparoscopic gynecological surgeries
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After SurgeryPreoperatively 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. | Drug | Group E |
| ControlPreoperatively, NPO 6 hours before the procedure Intraoperatively, on induction Nabuphine 0.1mg/kg | Drug | Group C |
Primary outcome
Length of hospital stay
Time frame: From arrival in the recovery room post-surgery until 72 hours after surgery.
Post-operative length of hospital stay, measured in hours from the patient's arrival in the recovery room until 72 hours after surgery.
3 secondary outcomes
Postoperative pain score
Time frame: 4 hours, 8 hours, 12 hours, 24 hours, 48 hours & 72 hours postoperatively
Amount of opioid used in patient controlled analgesia
Time frame: 12 hours postoperatively.
Patient satisfaction Score
Time frame: 24 hours after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Sarfraz Siddiqui, MBBS, MCPS, FCPS, FIPP, MHPE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enhanced Recovery After Surgery in people with ERAS, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Sarfraz Siddiqui, MBBS, MCPS, FCPS, FIPP, MHPE (+922134864397 ext. 4397, sarfraz.siddiqui@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From arrival in the recovery room post-surgery until 72 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.