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Decrease Post Laproscopy Shoulder and Abdominal PainPhase 4NCT03241602

Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain

A Phase 4 study testing Intraperitoneal lidocaine, Pulmonary Recruitment and Combined intraperitoneal lidocaine and pulmonary recruitment maneuver in people with Decrease Post Laproscopy Shoulder and Abdominal Pain, run by Cairo University at 1 site in Egypt.

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

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Intraperitoneal lidocaine, Pulmonary Recruitment and Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
15 Aug 2017to 30 Oct 2017
Phase
Phase 4
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine CAIRO UNIVERISTY

    Cairo

Other trials in Egypt

About this study

Official title: Multimodal Analgesic Technique for Control of Post-laproscopy Abdominal Pain in Patient Undergoing Diagnostic Gynacological Laproscopy. A Randomized Controlled Trial

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 :

Read more

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 .

Read the detailed description

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. Pain after Laparoscopy is considered to arise from 3 main sources: the incision sites (50% to 70%), the pneumoperitoneum (20% to 30%) in association with both local (peritoneal and diaphragmatic stretching, ischemia, acidosis) and systemic (hypercarbia causing sympathetic nervous system excitation resulting in amplification of the local tissue inflammatory response) changes, and the procedure site (10% to 20%) as postcholecystectomy wound within the liver. Pain can also be referred from the subdiaphragmatic region as shoulder pain. Shoulder pain is often mild in intensity and can remain for 24 hours. Incisional pain is usually mild to moderate in intensity, and maximal immediately postoperatively, subsiding with time. Local anaesthetic (LA) to be filtered preincisional can not entirely eliminate postoperative pain, especially shoulder pain, In contrast, Intraperitoneal local anaesthetic instillation is a known method of providing post-laparoscopy pain relief. Lidocaine is safe and effective in pain relief, improving respiratory functions and early return of bowel motility. The local anaesthetic blocks visceral nociception from the peritoneum locally as well as a having a systemic effect after absorption through the peritoneal surface . The systemic analgesic effect of LA is induced through an anti-inflammatory effect by peripheral suppression of acute chemically induced pain, inhibition of nerve conduction, as well as having a central antihyperalgesic effect. The pulmonary recruitment manoeuvre (RM) can mechanically remove residual carbon dioxide (CO2) after laparoscopic surgery, reduce phrenic nerve irritation, and consequently reduce post-laparoscopic shoulder and upper abdominal pain. The combined effect of these two methods ,using various local anaesthetics , on pain following laparoscopic procedures has not been reported. This study will investigate the efficacy of combining local anaesthetic infiltration of Lidocaine with pulmonary recruitment manoeuvre on postoperative pain following diagnostic Gynaecologic laparoscopy. For blinding, Pulmonary recruitment maneuver will be combined with intraperitoneal instillation of saline. However, intraperitoneal saline is a known simple maneuver to decrease shoulder pain. A possible explanation is that saline displaces residual pockets of gas from within the peritoneal cavity and thereby prevents loss of suction support between the liver and diaphragm. In this study we hypothesized that combining simple maneuver like pulmonary recruitment with intraperitoneal instillation of local anaesthetic would be more effective than pulmonary recruitment alone.

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

Study Methods

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 I or II , 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 (electrocardiography, pulse oximetry and non-invasive blood pressure measurement) will be applied to the patient.

Anaesthesia will be induced with propofol 2 mg/ kg, Fentanyl 1 mcg/ kg , 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. Veress needle is introduced at first through lower border of umbilicus and water test is done to ensure intraperitoneal placement. Then, reaching proper distension pressure is ensured by disappearance of dullness over lower border of the liver. The pressure will be about 15 mmHg. The patient will be placed in a Trendelenburg position in order to provide optimum conditions for laparoscopic view. A 10 mm laparoscopic trocar is introduced with 45 degree towards pelvis and zero camera is introduced through the cannula trocar. Second puncture can be done through right or left iliac fossae. 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 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. 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. 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 .

Being tested
Intraperitoneal lidocaine, Pulmonary Recruitment, Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
Medical subject headings
Abdominal Pain

What participants receive

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

  • Intraperitoneal lidocaineDrug

    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.

  • Pulmonary RecruitmentProcedure or surgery

    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

  • Combined intraperitoneal lidocaine and pulmonary recruitment maneuverCombination product

    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

Study groups in NCT03241602
Study groupRoleWhat they receive
group of Pulmonary recruitment & Intraperitoneal libocaiActive comparatorNot described
Receives: Combination Product: Combined intraperitoneal lidocaine and pulmonary recruitment maneuver
Group of Intraperitoneal lidocaineActive comparatorNot described
Receives: Drug: Intraperitoneal lidocaine
Group of pulmonary recruitmentActive comparatorNot described
Receives: Procedure: Pulmonary Recruitment
group receive passive exsufflation through portNo interventionNot described

What is being measured

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

  1. Postoperative pain measuring 6 hours postoperative

    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

    Measured: 6 hours post-oprative

Secondary outcomes (2)
  1. Post-operative Pain measuring Visual analogue scale 8 and 10 hour

    questionnaire will done for the patient at 8, 10 hour using VAS

    Measured: 8 , 10 Hours Post-operative

  2. Post-operative Nausea and Vomitting

    questionnaire

    Measured: 2 hours

Timeline

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

  1. First posted7 Aug 2017
  2. Study start15 Aug 2017
  3. Primary completion28 Oct 2017
  4. Study completion30 Oct 2017

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241602
Sponsor's protocol ID
N-61-2017
Status last verified
Jan 2018
First submitted
3 Aug 2017
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intraperitoneal lidocaine, Pulmonary Recruitment and Combined intraperitoneal lidocaine and pulmonary recruitment maneuver in people with Decrease Post Laproscopy Shoulder and Abdominal Pain, run by Cairo University at 1 site in Egypt.

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 6 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 25 Jan 2018. 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 Egypt. 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?

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?

Postoperative pain measuring 6 hours postoperative (time frame: 6 hours post-oprative). 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 25 Jan 2018.

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