Gynecologic DiseaseNCT04475809
Different Maneuvers for Reducing Post-laparoscopic Pain
A study testing group C, Group L and Group LR in people with Gynecologic Disease, run by Zagazig University at 1 site in Egypt.
Trial summary
Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- group C, Group L and Group LR
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2020to 1 Mar 2022
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient acceptance.
- BMI ≤35 kg/m2.
- ASA I and ASA II.
- Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under general anesthesia.
Who cannot join
- Patients with pre-existing chronic pain disorders.
- Patients on opioid or sedative use.
- Psychological and mental disorders.
- Severe hypertensive, cardiac, hepatic and renal patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Maneuvers for Reducing Post-laparoscopic Shoulder and Abdominal Pain: A Randomized Controlled Trial
- Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site
- Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however, the effect is limited, and there are no reliable methods available yet.
- Recently, some techniques are introduced that can potentially alleviate various types of pain through different mechanisms in patients after laparoscopic surgery such as low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary recruitment maneuvers.
- the investigators conduct this randomized controlled trial to evaluate the effectiveness of different strategies on reducing the intensity of post-laparoscopic shoulder and abdominal pain in patients undergoing laparoscopic gynecologic surgeries.
Read the detailed description
Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less postoperative pain, and earlier returns to normal activity . However post-laparoscopic shoulder and upper abdominal pain may upset the patient more than the pain at the incision site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35% to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.
The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal acidosis and consequent peritoneal irritation and abdominal pain.
As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and abdominal pain, many strategies have been evolved to alleviate different types of pain in patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair visualization and jeopardize the surgeon's comfort during surgery, this method is proven to be safe and feasible.
One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well as offers a physiologic buffer system to wash out excess CO2.
Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the elimination of residual CO2.
Because these variable techniques are mediated through different mechanisms, the investigators hypothesize that combination of two different maneuvers may be ideal and more effective in reducing post-laparoscopic shoulder and abdominal pain than any single or standard maneuver in patients undergoing laparoscopic gynecologic surgeries.
- Conditions
- Gynecologic Disease
- Being tested
- group C, Group L, Group LR, Group LS
- Keywords
- Pulmonary recruitment maneuvers, low-pressure pneumoperitoneum, laparoscopic Shoulder and Abdominal Pain, laparoscopic gynecologic surgery, intraperitoneal saline infusion
- Medical subject headings
- Genital Diseases, Female, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group CProcedure or surgery
laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.
Group LProcedure or surgery
laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.
Group LRProcedure or surgery
the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.
Group LSProcedure or surgery
the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | high intra-abdominal pressure Receives: Procedure: group C |
| Group L | Active comparator | low intra-abdominal pressure Receives: Procedure: Group L |
| Group LR | Active comparator | low intra-abdominal pressure with pulmonary recruitment maneuver group Receives: Procedure: Group LR |
| Group LS | Active comparator | low intra-abdominal pressure with intraperitoneal saline infusion group Receives: Procedure: Group LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in assessment of shoulder, abdominal and incisional pain
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Measured: at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively
Secondary outcomes (2)
Time of first request of analgesia
time elapsed from patient arrival to post anesthesia care unit to time of first patient call for analgesia
Measured: within 24 hour postoperative
Total rescue analgesic requirement
if VAS ≥3 or on patient request, rescue analgesia will be given
Measured: during the first postoperative 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start13 Jul 2020
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475809
- Sponsor's protocol ID
- 6251-1207-2020
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.
PubMed 30699235Tsai 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 22184293Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.
PubMed 22385527Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
PubMed 25361653Davari-Tanha F, Samimi S, Khalaj Z, Bastanhagh E. Comparison of Intraperitoneal Normal Saline Infusion with Pulmonary Recruitment Maneuver in Reducing Shoulder and Upper Abdomen Pain Following Gynecologic Laparoscopic Procedures: A Randomized, Controlled, Triple-Blind Trial. Anesth Pain Med. 2019 Jun 2;9(3):e92444. doi: 10.5812/aapm.92444. eCollection 2019 Jun.
PubMed 31497525Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
PubMed 20604657
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Maneuvers for Reducing Post-laparoscopic Shoulder and Abdominal Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04475809
- Acronym / sponsor ID
- 6251-1207-2020
- Conditions
- Gynecologic Disease
- Keywords
- Pulmonary recruitment maneuvers, low-pressure pneumoperitoneum, laparoscopic Shoulder and Abdominal Pain, laparoscopic gynecologic surgery, intraperitoneal saline infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 17 Jul 2020 (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.
- Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site
- Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however, the effect is limited, and there are no reliable methods available yet.
- Recently, some techniques are introduced that can potentially alleviate various types of pain through different mechanisms in patients after laparoscopic surgery such as low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary recruitment maneuvers.
- the investigators conduct this randomized controlled trial to evaluate the effectiveness of different strategies on reducing the intensity of post-laparoscopic shoulder and abdominal pain in patients undergoing laparoscopic gynecologic surgeries.
Detailed description
Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less postoperative pain, and earlier returns to normal activity . However post-laparoscopic shoulder and upper abdominal pain may upset the patient more than the pain at the incision site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35% to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.
The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal acidosis and consequent peritoneal irritation and abdominal pain.
As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and abdominal pain, many strategies have been evolved to alleviate different types of pain in patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair visualization and jeopardize the surgeon's comfort during surgery, this method is proven to be safe and feasible.
One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well as offers a physiologic buffer system to wash out excess CO2.
Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the elimination of residual CO2.
Because these variable techniques are mediated through different mechanisms, the investigators hypothesize that combination of two different maneuvers may be ideal and more effective in reducing post-laparoscopic shoulder and abdominal pain than any single or standard maneuver in patients undergoing laparoscopic gynecologic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Procedure: group Chigh intra-abdominal pressure |
| Group L | Active comparator | Procedure: Group Llow intra-abdominal pressure |
| Group LR | Active comparator | Procedure: Group LRlow intra-abdominal pressure with pulmonary recruitment maneuver group |
| Group LS | Active comparator | Procedure: Group LSlow intra-abdominal pressure with intraperitoneal saline infusion group |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient acceptance.
- BMI ≤35 kg/m2.
- ASA I and ASA II.
- Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under general anesthesia.
Key exclusion criteria (4 listed)
- Patients with pre-existing chronic pain disorders.
- Patients on opioid or sedative use.
- Psychological and mental disorders.
- Severe hypertensive, cardiac, hepatic and renal patients.
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 |
|---|---|---|
| group Claparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site. | Procedure or surgery | Group C |
| Group Llaparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure. | Procedure or surgery | Group L |
| Group LRthe intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consists of five manual pulmonary inflations at a maximum pressure of 40 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity. | Procedure or surgery | Group LR |
| Group LSthe intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight) | Procedure or surgery | Group LS |
Primary outcome
changes in assessment of shoulder, abdominal and incisional pain
Time frame: at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
2 secondary outcomes
Time of first request of analgesia
Time frame: within 24 hour postoperative
Total rescue analgesic requirement
Time frame: during the first postoperative 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 30699235Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.
- 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 22385527Yasir M, Mehta KS, Banday VH, Aiman A, Masood I, Iqbal B. Evaluation of post operative shoulder tip pain in low pressure versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy. Surgeon. 2012 Apr;10(2):71-4. doi: 10.1016/j.surge.2011.02.003. Epub 2011 Mar 21.
- Background: PubMed 25361653Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
- Background: PubMed 31497525Davari-Tanha F, Samimi S, Khalaj Z, Bastanhagh E. Comparison of Intraperitoneal Normal Saline Infusion with Pulmonary Recruitment Maneuver in Reducing Shoulder and Upper Abdomen Pain Following Gynecologic Laparoscopic Procedures: A Randomized, Controlled, Triple-Blind Trial. Anesth Pain Med. 2019 Jun 2;9(3):e92444. doi: 10.5812/aapm.92444. eCollection 2019 Jun.
- Background: PubMed 20604657Sharami SH, Sharami MB, Abdollahzadeh M, Keyvan A. Randomised clinical trial of the influence of pulmonary recruitment manoeuvre on reducing shoulder pain after laparoscopy. J Obstet Gynaecol. 2010;30(5):505-10. doi: 10.3109/01443611003802313.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
Related trials for Gynecologic Disease
RecruitingObservational study
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Gynecologic Cancer, Radiotherapy Side Effect
Not yet recruiting
ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
Gynecologic Disease
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
Recruiting
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Enhanced Recovery After Surgery, Gynecologic Disease
Active, not recruitingPhase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Advanced Solid Tumors, Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group C, Group L and Group LR in people with Gynecologic Disease, run by Zagazig 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 4 inclusion and 4 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 20 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
changes in assessment of shoulder, abdominal and incisional pain (time frame: at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively). 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 NCT04475809, which also lists 6 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 20 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.