Efficacy of Adding Dexmedetomidine Versus Ibuprofen as an Adjuvant to Intraperitoneal Bupivacaine for Pain Control After Laparoscopic Gynecological Procedures

September 14, 2023 updated by: Wael El GHARABAWY, Ain Shams University

Efficacy of Adding Dexmedetomidine Versus Ibuprofen as an Adjuvant to Intraperitoneal Bupivacaine for Pain Control After Laparoscopic Gynecological Procedures: a Double-blind Randomized Comparative Study

The goal of this clinical trial is to compare the analgesic efficacy of adding dexmedetomidine versus ibuprofen to bupivacaine for intraperitoneal instillation after laparoscopic gynecological procedures. The main questions to answer are:

  • Which is more effective for controlling postoperative pain within the first 24 hours after the procedure?
  • Which is more convenient for the patients with fewer side effects and opioid consumption?

Participants will be asked to assess

  • The postoperative pain severity by VAS score
  • The onset of the first analgesic request
  • The incidence of side effects like nausea and vomiting Researchers will compare the dexmedetomidine group, the ibuprofen group, and the bupivacaine (control) group to see which one will be superior to the others.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be randomly allocated by simple randomization using a computer program into two equal groups by closed envelope technique:

Group 1: Bupivacaine/Ibuprofen group (BI): Patients will receive 50ml bupivacaine 0.25% (125 mg) + 400 mg Ibuprofen diluted in 100 ml normal saline.

Group 2: Bupivacaine/Dexmedetomidine group (BD): Patients will receive 20 ml bupivacaine 0.25% (125 mg) + 1 µq/kg dexmedetomidine diluted in 100 ml normal saline.

Group 3: Control group/Bupivacaine group (B): Patients will receive 50 ml Bupivacaine 0.25% (125mg) diluted in 100 ml normal saline.

All the previous drugs will be injected intraperitoneally through trocars at the end of the surgery.

All patients will be assessed preoperatively by careful history taking, full physical examination, laboratory evaluation, and other appropriate investigations.

At the preoperative visit, all patients will be instructed on how to evaluate their pain by using the visual analog scale (VAS) (range from 0-10., 0 =no pain, 10 = worst pain).

  • Intraoperative settings:

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg. All patients will be intubated with an endotracheal tube and mechanically ventilated to maintain normocarbia. Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg) at the discretion of the attending anesthesiologist. All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg.

At the end of the procedure injections will be given by the surgeon through trocars intraperitoneally, then isoflurane will be discontinued and, the neuromuscular blockade will be antagonized by using neostigmine 0.05mg/kg plus atropine 0.01 mg/kg after assessment by nerve stimulator according to the train of four and will be administered to reverse the effect of rocuronium. then the trachea will be extubated, all patients will be transferred to the post-anesthesia unit (PACU). After completion of the surgical procedure, patients will be transferred to the post-anesthetic care unit (PACU), and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9.

To achieve blinding, the study drugs will be prepared in a ready-to-inject form by a separate anesthesiologist who is not involved in the study. This way, neither the patient nor the anesthesiologist administering the drug will be aware of the type of medication being used. The physician who will gather patient data is also unaware of the medications administered. During the first 24 hours After surgery, all patients will receive post-operative pain protocol (1 gm paracetamol IV every 8 hr.).

Pethidine 0.5 mg/kg diluted in 5 ml, titrated IV as rescue analgesia if VAS is greater than 3, or at any time the patient demands additional analgesia.

In the presence of nausea, with or without vomiting, granisetron 1 mg will be given intravenously and repeated if nausea persists (maximum dose of 3 mg per day).

Complications including postoperative nausea, vomiting, and other complications related to the drug used (e.g., toxicity,) will be recorded up to 24 hours after surgery.

The intensity of postoperative abdominal and shoulder pain will be measured on arrival in the recovery room and subsequently at time intervals of 2, 4, 6, 12, and 24 h using a 10-cm linear visual analog scale (VAS). The scale consisted of a horizontal line marked ''no pain' at one end and ''worst pain' at the other. Abdominal pain scores were measured at rest (supine), with activity (sitting up from supine), and with coughing. The time interval from extubation to the first administration of nalbuphine will be registered. The consumption of postoperative analgesics was recorded. Side effects (nausea, vomiting, sweating, dizziness, tinnitus, muscular twitches, and circumoral numbness), and recovery variables (return of bowel function, time interval to ambulation, resumption of liquid intake, and hospital discharge) will be assessed by the ward nurses at 2-h intervals. Patients were immediately given 1 mg intravenous granisetron and repeated if nausea persisted (maximum dose of 3 mg per day).

if they experience nausea or vomiting. Patients will be deemed ready for discharge from the hospital when they are afebrile, vital signs are stable, oral nutrition (liquid) was tolerated without discomfort, and bowel function has returned. Bowel recovery time was defined as the time from the end of anesthesia until the presence of good intestinal sound (estimated by the same surgeon) or the first passage of flatus.

Outcome measures:

  • Primary outcome:

    > Post-operative pain severity by VAS (at 0 (the point of full recovery state at PACU), 6 hr., 12 hr., 18 hr., and 24 hr.) will be assessed.

  • Secondary outcomes:

    • Cumulative postoperative opioid consumption (total amount of opioid consumption) in the first 24 hours postoperatively.
    • The onset of the first analgesic request. (Time of rescue analgesia).
    • Patient satisfaction after 1st postoperative day (four-point scale (1 =excellent, 2= good, 3= fair,4= poor)).
    • Incidence of postoperative nausea and vomiting.
    • Incidence of complications (LA toxicity,).
    • The hemodynamics of the patients (mean ABP, HR) will be measured at 0 hr., 6 hr., 12 hr., 18 hr., and 24 hr. after surgery.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with American Society of Anesthesiologists (ASA) physical status 1-2 scheduled for a Laparoscopic gynecological procedure.

Exclusion Criteria:

  • History of allergy to the medications used in the study.
  • Contraindication as local infection at the site of port insertion.
  • Severe cardiac (NYHA ≥Ⅲ or pulmonary dysfunction (known COPD, previous thoracic surgeries, or recent pulmonary infection).
  • Severe hepatic impairment (Child C) (INR≥2, Albumin≤2.5).
  • Severe Renal dysfunction (creatinine clearance < 30).
  • Neurologic, a psychiatric or mental disorder affecting the patient's ability to interpret VAS score.
  • Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
  • Patients who were converted to open surgery.
  • ASA Ⅲ-Ⅳ.
  • Patient refusal.
  • Emergency operations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Bupivacaine group (Group B) (control group)
Patients will receive 50 ml of Bupivacaine 0.25% (125mg) diluted in 100 ml of normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
Drug: Administering intraperitoneal bupivacaine for pain control after laparoscopic gynecological procedures

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg.

Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg).

All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg.

At the end of the procedure bupivacaine injection will be given by the surgeon through trocars intraperitoneally.

Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9.

During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.
Experimental: Bupivacaine/Ibuprofen group (Group BI)
Patients will receive 50 ml of Bupivacaine 0.25% (125 mg) + 400 mg Ibuprofen diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
Drug: Administering intraperitoneal bupivacaine plus Ibuprofen for pain control after laparoscopic gynecological procedures

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg.

Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg).

All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg.

At the end of the procedure bupivacaine plus Ibuprofen injection will be given by the surgeon through trocars intraperitoneally.

Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9.

During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.
Active Comparator: Bupivacaine/Dexmedetomidine group (Group BD):
Patients will receive 20 ml of bupivacaine 0.25% (125 mg) + 1 µq/kg dexmedetomidine diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.
Drug: Administering intraperitoneal bupivacaine plus Dexmedetomidine for pain control after laparoscopic gynecological procedures

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg.

Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg).

All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg.

At the end of the procedure bupivacaine plus Dexmedetomidine injection will be given by the surgeon through trocars intraperitoneally.

Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9.

During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on postoperative pain control
Time Frame: 24 hours after the procedure
Assessment of postoperative pain severity by Visual analog score (VAS score) (at 0 (the point of full recovery state at PACU), 6 hr., 12 hr., 18 hr., and 24 hr. after the end of the procedure) will be assessed.
24 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 24 hours after the procedure
Cumulative postoperative opioid consumption (total amount of opioid consumption) in the first 24 hours postoperatively.
24 hours after the procedure
The onset of the first analgesic request
Time Frame: Within 24 hours after the procedure
The onset of the first analgesic request. (Time of rescue analgesia). we will document the time when the patient asks for rescue analgesia
Within 24 hours after the procedure
Patient satisfaction
Time Frame: After 24 hours of the procedure
Patient satisfaction after first postoperative day (four-point scale (1 =excellent, 2= good, 3= fair,4= poor)).
After 24 hours of the procedure
Incidence of postoperative side effects
Time Frame: Within 24 hours after the procedure
Incidence of postoperative side effects like nausea and vomiting
Within 24 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R131/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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