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Opioid Free AnesthesiaNCT07138053

The Impact Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

A study testing OFA group in people with Opioid Free Anesthesia and Stress Response, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery. Hypothesis was: opioid free anesthesia reduces postoperative pain intensity and stress response in terms of the value for pain in VAS (Visual Analog… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
OFA group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBosnia and Herzegovina
Study dates
22 Aug 2025to 30 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • body mass index above 30 kg/m2,
  • diabetes mellitus requiring insulin therapy,
  • emergence surgery,
  • cardiopulmonary disease,
  • neuromuscular disease,
  • renal disease,
Show all 15Show fewer
  • vaginal hysterectomy,
  • hepatic or endocrine disease,
  • pregnancy,
  • mental disease,
  • allergy to any study drugs,
  • alcoholic or drug abuse,
  • ASA III and IV,
  • patient's refusal to participate in the study,
  • duration of surgery below 30min and over 90min.

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site

  • Cantonal Hospital Zenica

    Zenica, Zenica, 7200

Other trials in Bosnia and Herzegovina

About this study

Official title: The Impact of Multimodal Balancing Anesthesia vs Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

This study compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery.

Hypothesis was: opioid free anesthesia reduces postoperative pain intensity and stress response in terms of the value for pain in VAS (Visual Analog Scala) and for stress response in value of cortisol, prolactin and IL-6, CRP and improves postoperative patients subjective well-being and surgical outcome.

Read the detailed description

This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Gynecology at the Cantonal Hospital Zenica, Bosnia and Herzegovina. After obtaining ethical committee approval 70 participants, scheduled for elective open gynecology surgery were included into study. Sample size was calculated a priori using G*Power software (version 3.1.9.7; Heinrich Heine University, Düsseldorf, Germany). Assuming a large effect size (Cohen's d = 0.80) for the primary outcome, a two-sided significance level of α = 0.05 and a statistical power of 80%, a minimum sample size of 35 patients per group was required. To account for potential dropouts and protocol deviations, 40 patients were enrolled in each study group.

All statistical tests were two-sided, and P < 0.05 was considered statistically significant.

Secondary outcomes included serum prolactin, blood glucose, NLR, LMR IL-6, CRP, VAS, PONV and postoperative quality of recovery assessed using the QoR-15 questionnaire.

Assuming dropout would lead to a total sample size of 70 participants. Before each participant agreed to the join the study, the purpose and procedures of the study were fully explained and informed and written consent was obtained from each participant. A preoperative anesthetic examination was conducted the day before surgery. The interventional group, opioid free anesthesia group (OFA group) and the control group, multimodal balancing anesthesia group (MBA group). Randomization was performed by computer generated randomization codes. The codes which indicated the treatment were held in sealed opaque envelopes. Nurse who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the gynecologist, nurses and staff involved in data collection.

The participants of MBA group were undergone to the traditional concept of preoperative and intraoperative anesthesia management with opioid. The participants in the intervention group received opioid free anesthesia and didn't received opioid in preoperative period. Assessment of clinical parameters started at 06:00 am on the day of surgery (basal value). Peripheral venous blood samples were collected to measure serum levels of glucose, cortisol, prolactin, C-reactive protein, blood count and differential blood count and IL-6, and 06.00 am on the first postoperative day. Six hours post-surgery peripheral venous blood samples were collected to measure serum levels of glucose, cortisol, prolactin, blood count and differential blood count. All patients underwent to opioid free anesthesia will be given TAP block ultrasound guided after intubation and before surgical incision. Consciousness and pain respond monitored by Entropy or CONX device. Analgesia for opioid free arm during surgery will be provided with combination of medicament (Dexmedetomidine, Ketamine, 2%Lidocaine, Dexamethasone and Magnesium sulfate). Blood pressure and hart rate recorded : before intubation, on intubation, skin incision, before extubation and two hour after extubation.

Assessment of subjective well-being was performed using a 10 cm horizontal Visual Analogue Scales for 1, 2, 4, 6,12, 24 and 48 hours post-surgery. Pain at rest, pain with mobilization, thirst, hunger, mouth dryness, anxiety and weakness were evaluated. The patients were explained how to use the scale. Postoperative quality of recovery assessed using the QoR-15 questionnaire at 24 and 48 h after surgery.

Postoperative data included and the time to oral intake. The following data were recorded also: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, type of surgery.

Being tested
OFA group
Keywords
opioid, cortisol, stress response
Medical subject headings
Fractures, Stress, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OFA groupOther

    OFA group Participants received intravenous midazolam (3 mg) and paracetamol (1 g) approximately 30 min before surgery. After standard monitoring was established, magnesium sulfate (40 mg/kg) was administered intravenously over 10 min, followed by dexamethasone (6 mg) before induction.

    Dexmedetomidine (0.7-1.0 μg/kg) and lidocaine (1.5 mg/kg) loading doses were initiated 10 min before induction. Anaesthesia was induced with propofol (2 mg/kg/TT) and and vecuronium bromide (0.1 mg/kg). Ketamine (0.5-1.0 mg/kg) was administered immediately before tracheal intubation, with further doses when clinically indicated. Anaesthesia was maintained with sevoflu and Dexmedetomidine (0.5-1.0 μg/kg/h) and lidocaine (1.0-1.5 mg/kg/h) infusion discontinued after last surgical sutures. TAP bloc ultrasound guided performed after intubation. Ketamine given 60 sec before incision in doses 0.5 mg/kg, and after if it is necessary according to ER and qNOX. Provided value range between 40-60 during surgery.

Study groups in NCT07138053
Study groupRoleWhat they receive
MBA groupNo interventionanesthesia based on opioids (multimodal balancing anesthesia with opioids)
OFA groupExperimentalExperimental group will not receive opioids in perioperativ period
Receives: Other: OFA group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative serum cortisol concentration

    Serum cortisol concentration was measured in peripheral venous blood samples at three predefined perioperative time points. Cortisol concentrations at each time point were used to characterize the perioperative cortisol response and to compare the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline), 6 hours after completion of surgery, and at 06:00 on the first postoperative day.

Secondary outcomes (8)

  1. Perioperative serum interleukin-6 (IL-6) concentration

    Serum interleukin-6 (IL-6) concentration was measured in peripheral venous blood samples at two predefined perioperative time points. IL-6 concentrations at each time point were compared between the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline) and at 06:00 on the first postoperative day.

  2. Perioperative serum prolactin concentration

    Serum prolactin concentration was measured in peripheral venous blood samples at three predefined perioperative time points. Prolactin concentrations at each time point were used to characterize the perioperative prolactin response and to compare the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline), 6 hours after completion of surgery, and at 06:00 on the first postoperative day.

  3. Visual Analogue Scale (VAS) scores

    Postoperative pain and subjective well-being were assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10, with 0 indicating no symptom and 10 indicating the worst imaginable symptom. Pain was assessed at rest and during movement. Highest score mean worst outcome.

    Measured: At 1, 3, 6, 12, 24, and 48 hours after surgery

  4. Quality of recovery 15 (QoR-15)

    Postoperative quality of recovery assessed using the QoR-15 questionnaire. The Quality of Recovery-15 (QoR-15) is a validated 15-item instrument covering pain, physical comfort, emotional state, physical independence and psychological support, with a score range of 0-150 in which higher scores indicate better recovery.

    Measured: at 24 and 48 hours after surgery

  5. Neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR)

    The neutrophil-to-lymphocyte ratio (NLR) was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The lymphocyte-to-monocyte ratio (LMR) was calculated by dividing the absolute lymphocyte count by the absolute monocyte count. NLR and LMR values were determined at three predefined perioperative time points and compared between the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline), 6 hours after completion of surgery, and at 06:00 on the first postoperative day.

  6. Blood glucose concentration

    Blood glucose concentration was measured in peripheral venous blood samples at three predefined perioperative time points. Blood glucose concentrations at each time point were compared between the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline), 6 hours after completion of surgery, and at 06:00 on the first postoperative day.

  7. Perioperative serum C-reactive protein (CRP) concentration

    Serum C-reactive protein concentration was measured in peripheral venous blood samples at two predefined perioperative time points. CRP concentrations at each time point were compared between the two study groups.

    Measured: At 06:00 on the day of surgery before anaesthesia (baseline) and at 06:00 on the first postoperative day.

  8. Postoperative nausea and vomiting (PONV)

    Postoperative nausea and vomiting (PONV) were recorded as present or absent at each assessment time point.

    Measured: At 1, 3, 6, 12, 24, and 48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start22 Aug 2025
  3. Primary completion28 Mar 2026
  4. Study completion30 Mar 2026

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The diagnostic protocol was performed in patients at the gynecology department. The patients with diagnosed non cancer pathology and who needed gynecolog surgery were prepared for the surgical procedure. After that, patients were examined to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07138053
Sponsor's protocol ID
ALJ07/25
Status last verified
Aug 2025
First submitted
15 Aug 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xia M, Ji NN, Duan ML, Tong JH, Xu JG, Zhang YM, Wang SH. Dexmedetomidine regulate the malignancy of breast cancer cells by activating alpha2-adrenoceptor/ERK signaling pathway. Eur Rev Med Pharmacol Sci. 2016 Aug;20(16):3500-6.

    PubMed 27608913

  • Lersch F, Correia PC, Hight D, Kaiser HA, Berger-Estilita J. The nuts and bolts of multimodal anaesthesia in the 21st century: a primer for clinicians. Curr Opin Anaesthesiol. 2023 Dec 1;36(6):666-675. doi: 10.1097/ACO.0000000000001308. Epub 2023 Sep 19.

    PubMed 37724595

  • Jameson P, Desborough JP, Bryant AE, Hall GM. The effect of cortisol suppression on interleukin-6 and white blood cell responses to surgery. Acta Anaesthesiol Scand. 1997 Feb;41(2):304-8. doi: 10.1111/j.1399-6576.1997.tb04683.x.

    PubMed 9062617

  • Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.

    PubMed 28742427

  • Anand S, Bhati G, Gurram R, Gnanasekaran S, Kate V, Pottakkat B, Kalayarasan R. Does Neutrophil-to-Lymphocyte Ratio (NLR) Predict Pathologic Response to Neoadjuvant Chemoradiotherapy in Patients with Esophageal Squamous Cell Carcinoma? J Gastrointest Cancer. 2021 Jun;52(2):659-665. doi: 10.1007/s12029-020-00445-5.

    PubMed 32607960

  • Akeju O, Song AH, Hamilos AE, Pavone KJ, Flores FJ, Brown EN, Purdon PL. Electroencephalogram signatures of ketamine anesthesia-induced unconsciousness. Clin Neurophysiol. 2016 Jun;127(6):2414-22. doi: 10.1016/j.clinph.2016.03.005. Epub 2016 Mar 16.

    PubMed 27178861

  • Akeju O, Hobbs LE, Gao L, Burns SM, Pavone KJ, Plummer GS, Walsh EC, Houle TT, Kim SE, Bianchi MT, Ellenbogen JM, Brown EN. Dexmedetomidine promotes biomimetic non-rapid eye movement stage 3 sleep in humans: A pilot study. Clin Neurophysiol. 2018 Jan;129(1):69-78. doi: 10.1016/j.clinph.2017.10.005. Epub 2017 Oct 20.

    PubMed 29154132

Questions about this trial

What is this clinical trial studying?

A study testing OFA group in people with Opioid Free Anesthesia and Stress Response, run by Cantonal Hospital Zenica at 1 site in Bosnia and Herzegovina.

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 0 inclusion and 15 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: finished, as of the sponsor's last update on 2 Nov 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 Bosnia and Herzegovina. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative serum cortisol concentration (time frame: At 06:00 on the day of surgery before anaesthesia (baseline), 6 hours after completion of surgery, and at 06:00 on the first postoperative day.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07138053, which also lists 7 linked publications.

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 2 Nov 2026.

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