Laparoscopic Gynecological SurgeryPhase 4NCT03845608
Analgesic Effect of Pulmonary Recruitment and Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
A Phase 4 study testing Pulmonary Recruitment Maneuver in people with Laparoscopic Gynecological Surgery, run by Cairo University.
Trial summary
The aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgery
- What is being tested?
- Pulmonary Recruitment Maneuver
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Nov 2019
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • female gender, age 20-45 years undergoing laparoscopic gynecological operations
- American Society of Anesthesiologist physical status classification of I or II
Who cannot join
- • Patients younger than 20 years or older than 45 years
- History of chronic pain
- Regular medication with analgesics, or steroids
- Analgesic use within 24 h of surgery ,drug or alcohol abuse
- Associated chronic diseases like diabetes mellitus, pulmonary diseases ,poor cardiac reserve,hepatorenal insufficiency.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
The aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery.
Read the detailed description
Laparoscopic surgeries are becoming more attractive because of an early recovery . However, post laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site.
Proper pain relief is a major concern and area of focus. Pre-operatively, one of the most common questions asked by patients about the amount of pain they will experience after the surgery. Pain has been found to be one of the three most common medical causes of delayed discharge after ambulatory surgery, the other two being drowsiness and nausea and vomiting. Unfortunately prevention and treatment of postoperative pain continues to be a major challenge in postoperative care.
Good pain control after surgery is important to prevent negative outcomes such as tachycardia, hypertension, myocardial ischemia, decrease in alveolar ventilation, and poor wound healing.
Pain also can prolong hospital stay, which is particularly important in day case procedures.
The mechanism of laparoscopy induced shoulder pain is mainly derived from carbon dioxide retention within the abdomen, subsequently irritating the phrenic nerve and causing referred pain in the C4 dermatome. Moreover, carbon dioxide trapped between the liver and the right diaphragm, irritating the diaphragm, also causes upper abdominal pain.
Although there are many analgesic drugs available for postoperative pain, many patients still find them to be suboptimal for controlling pain.
Many strategies, including treatment with non steroidal anti-inflammatory drugs, have been used to try to reduce laparoscopy-induced shoulder pain however, no sufficiently reliable methods have been reported yet .
Also Intraperitoneal local anesthetic was tried as an important addition for postoperative pain in the era of modern surgery. The method of delivering local anesthetic directly to the intraperitoneal cavity was first described in 1951 by Griffin et al. ; however, this method was forgotten for many years until its implementation in minimal access surgery was reappeared. It significantly reduces postoperative pain and opioid consumption after laparoscopic gynecological and general surgical operations.
Another effective method is the pulmonary recruitment maneuver (PRM) which can mechanically remove residual carbon dioxide and therefore decreasing peritoneal irritation, and shoulder pain.
Intravenous steroids have been used successfully for postoperative pain relief in different kinds of surgery . Also intraperitoneal hydrocortisone was has been used effectively to reduce pain after laparoscopic cholecystectomy.
In addition combination of intraperitoneal local anesthetics with hydrocortisone was proved to be a successful method in controlling upper abdominal and shoulder pain after laparoscopic procedures.
- Conditions
- Laparoscopic Gynecological Surgery
- Being tested
- Pulmonary Recruitment Maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Recruitment ManeuverCombination product
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Recruitment Maneuver | Experimental | Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity Receives: Combination Product: Pulmonary Recruitment Maneuver |
| Intraperitoneal Hydrocortisone | Other | Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum Receives: Combination Product: Pulmonary Recruitment Maneuver |
| control group | No intervention | In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first 24 hours total analgesic consumption.
Total amount of opioid drugs used after surgery for assessment of post operative pain
Measured: 24 hours after surgery
Secondary outcomes (2)
Length of the recovery and hospital stay (hours)
Duration between end of operation and patient discharge from hospital
Measured: 24 hours postoperative
Incidence of postoperative nausea ,vomiting or abdominal distension(%)
gastrointestinal complications after surgery
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study startMar 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Gynecological SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
- Investigators
- Nesrine El-Refai, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845608
- Sponsor's protocol ID
- pain and laparoscopic surgery
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kluivers KB, Johnson NP, Chien P, Vierhout ME, Bongers M, Mol BW. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):3-8. doi: 10.1016/j.ejogrb.2007.06.004. Epub 2007 Dec 11.
PubMed 18063290Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.
PubMed 20351978Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.
PubMed 8694166Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
PubMed 9389858Kahokehr A. Intraperitoneal local anesthetic for postoperative pain. Saudi J Anaesth. 2013 Jan;7(1):5. doi: 10.4103/1658-354X.109554. No abstract available.
PubMed 23717222Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PubMed 22184293Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
PubMed 18448749Safavi M, Honarmand A, Habibabady MR, Baraty S, Aghadavoudi O. Assessing intravenous ketamine and intravenous dexamethasone separately and in combination for early oral intake, vomiting and postoperative pain relief in children following tonsillectomy. Med Arh. 2012;66(2):111-5. doi: 10.5455/medarh.2012.66.111-115.
PubMed 22486143
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03845608
- Acronym / sponsor ID
- pain and laparoscopic surgery
- Conditions
- Laparoscopic Gynecological Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 19 Feb 2019 (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 aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery.
Detailed description
Laparoscopic surgeries are becoming more attractive because of an early recovery . However, post laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site.
Proper pain relief is a major concern and area of focus. Pre-operatively, one of the most common questions asked by patients about the amount of pain they will experience after the surgery. Pain has been found to be one of the three most common medical causes of delayed discharge after ambulatory surgery, the other two being drowsiness and nausea and vomiting. Unfortunately prevention and treatment of postoperative pain continues to be a major challenge in postoperative care.
Good pain control after surgery is important to prevent negative outcomes such as tachycardia, hypertension, myocardial ischemia, decrease in alveolar ventilation, and poor wound healing.
Pain also can prolong hospital stay, which is particularly important in day case procedures.
The mechanism of laparoscopy induced shoulder pain is mainly derived from carbon dioxide retention within the abdomen, subsequently irritating the phrenic nerve and causing referred pain in the C4 dermatome. Moreover, carbon dioxide trapped between the liver and the right diaphragm, irritating the diaphragm, also causes upper abdominal pain.
Although there are many analgesic drugs available for postoperative pain, many patients still find them to be suboptimal for controlling pain.
Many strategies, including treatment with non steroidal anti-inflammatory drugs, have been used to try to reduce laparoscopy-induced shoulder pain however, no sufficiently reliable methods have been reported yet .
Also Intraperitoneal local anesthetic was tried as an important addition for postoperative pain in the era of modern surgery. The method of delivering local anesthetic directly to the intraperitoneal cavity was first described in 1951 by Griffin et al. ; however, this method was forgotten for many years until its implementation in minimal access surgery was reappeared. It significantly reduces postoperative pain and opioid consumption after laparoscopic gynecological and general surgical operations.
Another effective method is the pulmonary recruitment maneuver (PRM) which can mechanically remove residual carbon dioxide and therefore decreasing peritoneal irritation, and shoulder pain.
Intravenous steroids have been used successfully for postoperative pain relief in different kinds of surgery . Also intraperitoneal hydrocortisone was has been used effectively to reduce pain after laparoscopic cholecystectomy.
In addition combination of intraperitoneal local anesthetics with hydrocortisone was proved to be a successful method in controlling upper abdominal and shoulder pain after laparoscopic procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Recruitment Maneuver | Experimental | Combination Product: Pulmonary Recruitment ManeuverPulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity |
| Intraperitoneal Hydrocortisone | Other | Combination Product: Pulmonary Recruitment ManeuverDrug Injection: 100mg of Hydrocortisone will be injected In the peritoneum |
| control group | No intervention | –In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • female gender, age 20-45 years undergoing laparoscopic gynecological operations
Key exclusion criteria (5 listed)
- • Patients younger than 20 years or older than 45 years
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 |
|---|---|---|
| Pulmonary Recruitment ManeuverPulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation | Combination product | Intraperitoneal Hydrocortisone, Pulmonary Recruitment Maneuver |
Primary outcome
The first 24 hours total analgesic consumption.
Time frame: 24 hours after surgery
Total amount of opioid drugs used after surgery for assessment of post operative pain
2 secondary outcomes
Length of the recovery and hospital stay (hours)
Time frame: 24 hours postoperative
Incidence of postoperative nausea ,vomiting or abdominal distension(%)
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Background: PubMed 18063290Kluivers KB, Johnson NP, Chien P, Vierhout ME, Bongers M, Mol BW. Comparison of laparoscopic and abdominal hysterectomy in terms of quality of life: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):3-8. doi: 10.1016/j.ejogrb.2007.06.004. Epub 2007 Dec 11.
- Background: PubMed 20351978Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010 Mar;83(1):11-25.
- Background: PubMed 8694166Jackson SA, Laurence AS, Hill JC. Does post-laparoscopy pain relate to residual carbon dioxide? Anaesthesia. 1996 May;51(5):485-7. doi: 10.1111/j.1365-2044.1996.tb07798.x.
- Background: PubMed 9389858Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.
- Background: PubMed 23717222Kahokehr A. Intraperitoneal local anesthetic for postoperative pain. Saudi J Anaesth. 2013 Jan;7(1):5. doi: 10.4103/1658-354X.109554. No abstract available.
- Background: PubMed 22184293Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
- Background: PubMed 18448749Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
- Background: PubMed 22486143Safavi M, Honarmand A, Habibabady MR, Baraty S, Aghadavoudi O. Assessing intravenous ketamine and intravenous dexamethasone separately and in combination for early oral intake, vomiting and postoperative pain relief in children following tonsillectomy. Med Arh. 2012;66(2):111-5. doi: 10.5455/medarh.2012.66.111-115.
- 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. This study is not recruiting at the moment.
Nesrine El-Refai, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pulmonary Recruitment Maneuver in people with Laparoscopic Gynecological Surgery, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atef Abdelmawla (01286970031, dratef@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first 24 hours total analgesic consumption. (time frame: 24 hours after surgery). 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 NCT03845608, which also lists 8 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 19 Feb 2019.