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Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain

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ClinicalTrials.gov Identifier: NCT03241602
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Sherin Refaat, Cairo University

Brief Summary:

The advancement of laparoscopy and minimal access surgery has greatly influenced the evolution of anaesthetic techniques. However, postoperative pain intensity may be significant, with up to 40% of patients unsatisfied by routine analgesia and up to 80%may require rescue opioids during their hospital stay. Diagnostic gynaecological laparoscopy has no origin of pain other than the abdominal gas insufflations itself only. Pain relief after diagnostic laparoscopy, being a day case, is an issue of great practical importance.The aim of this study is to compare the efficacy of combining both pulmonary recruitment and intraperitoneal lidocaine versus pulmonary recruitment alone to control post - laparoscopy shoulder pain regarding severity and frequency

Study Design :

Interventional Prospective Randomized Double-blind Controlled Trial

Methodology This study is a randomized double blinded control trial. It will be conducted at Kasr-al ainy hospital, faculty of medicine, Cairo university. Approval of ethical committee and written informed consent will be obtained. 88 female patients, aged 18-45 years , ASA 1 or 2 , scheduled for diagnostic gynaecologic laparoscopy will be included. Females who are (ASA) ≥ 3, alcoholic, drug abusers, allergic to amide LAs, with pre-existing chronic pain disorders, or receiving opioids or tranquilizers for > 1 week preoperatively are excluded. Also if the operation included any interventional procedure or was converted to an open procedure, or had postoperative complications that could increase postoperative pain, it will be excluded. Consenting patients will be randomly allocated to either of three study groups : GPL : Patients will receive pulmonary recruitment maneuver and intraperitoneal lidocaine. GPS: Patients will receive pulmonary recruitment maneuver and intraperitoneal saline. GC : Patients will receive passive exsufflation through the port site. The patient will attend at the pre anaesthetic room 1 hour before the procedure. A 20 Gauge cannula will be inserted peripherally and the patient will be premedicated with intravenous Midazolam 0.02 mg kg-1, Ranitidine 50 mg, 10 mg Metoclopramide.

In the operative room, standard monitoring will be applied to the patient. Anaesthesia will be induced with propofol 2 mg kg-1, Fentanyl 1 mcg kg-1 , Atracurium 0.5 mg kg-1 and the trachea will be intubated after mask ventilation for 3 minutes. Anaesthesia will be maintained with IPPV , isoflurane in 100% oxygen and muscular relaxation with atracurium 0.1mg kg-1every 15 minutes. Depth of anaesthesia was adjusted according to clinical signs. Laparoscopy is done using CO2 as distension medium. The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view. In groups GPL and GPS , the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. This ensures the surgeon and the anaesthesiologist are blind to the patient's group. The solution to be instilled will be splashed under the right diaphragmatic area by the surgeon and complete the procedure. At the end of the procedure, the patient will be placed back from trendelenburg position. In groups GPL and GPS , a pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anesthesiologist hold the fifth positive pressure inflation for approximately 5 seconds. In group GC CO2 will be removed by passive exsufflation through the port site and gentle abdominal pressure will be applied to evacuate the residual gas. Residual neuromuscular block is antagonized with atropine 1.2 mg and neostigmine 2.5 mg and extubation will be done according to extubation criteria. In the recovery room, patient will be asked about post-operative pain and it'll be controlled using Meperidine 1 mg kg-1 and given by a nurse who is unaware of the nature of the intraoperative analgesia. Then, the patient is discharged to the ward according to the standard criteria. In the ward, patient will be asked to fulfill a questionnaire at 6, 8 and 10 hours postoperative using the visual analogue score (VAS) of pain severity. Patients were questioned as to presence of Side effects (nausea, vomiting).

Possible Risk : Pneumothorax , Local anaesthetic toxicity : CNS depression (lightheadedness and dizziness, difficulty focusing, tinnitus, confusion, and circumoral numbness) , excitation ( tremors tonic-clonic convulsions) , respiratory depression and cardiac dysrhythmias .


Condition or disease Intervention/treatment Phase
Decrease Post Laproscopy Shoulder and Abdominal Pain Drug: Intraperitoneal lidocaine Procedure: Pulmonary Recruitment Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain in Patient Undergoing Diagnostic Gynacological Laproscopy. A Randomized Controlled Trial
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : October 28, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain
Drug Information available for: Lidocaine

Arm Intervention/treatment
Active Comparator: group of Pulmonary recruitment & Intraperitoneal libocai Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure before the recovery of the patient pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds

Active Comparator: Group of Intraperitoneal lidocaine Drug: Intraperitoneal lidocaine
the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure.

Active Comparator: Group of pulmonary recruitment Procedure: Pulmonary Recruitment
pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds

No Intervention: group receive passive exsufflation through port



Primary Outcome Measures :
  1. Postoperative pain measuring 6 hours postoperative [ Time Frame: 6 hours post-oprative ]
    post-operative pain measured using Visual Analogue Scale ,The patients were asked to complete a 10-cm linear analogue scale for shoulder pain, which ranged from 0 for no pain at all to 10 for the worst pain imaginable


Secondary Outcome Measures :
  1. Post-operative Pain measuring Visual analogue scale 8 and 10 hour [ Time Frame: 8 , 10 Hours Post-operative ]
    questionnaire will done for the patient at 8, 10 hour using VAS

  2. Post-operative Nausea and Vomitting [ Time Frame: 2 hours ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   as the selected surgery is diagnostic laparoscopy done only for female as this type of surgery there will be no source of pain other than abdominal distension
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female patients, aged 18-45 years scheduled for diagnostic Gynaecologic laparoscopy.
  2. American Society of Anesthesiology physical status 1 or 2.

Exclusion Criteria:

  1. American Society of Anesthesiology (ASA) physical status ≥ 3
  2. Allergy or hypersensitivity to amide type local anaesthetics;
  3. Pre-existing chronic pain disorders;
  4. Receiving opioids or tranquilizers for > 1 week preoperatively;
  5. History of alcohol or drug abuse.
  6. If the operation included any interventional procedure or was converted to an open procedure, or had postoperative complications that could increase postoperative pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241602


Locations
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Egypt
Faculty of medicine CAIRO UNIVERISTY
Cairo, Egypt
Sponsors and Collaborators
Cairo University

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Responsible Party: Sherin Refaat, lecturer of Anesthiology at faculty of medicine Cairo univeristy, Cairo University
ClinicalTrials.gov Identifier: NCT03241602     History of Changes
Other Study ID Numbers: N-61-2017
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Lidocaine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action