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Post Operative PainNCT06508814

Pain With Differing Insufflation Pressures During Laparoscopic Hysterectomy

A study testing Lower Insufflation Pressure and Standard Insufflation Pressure in people with Post Operative Pain, run by University of Tennessee at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Post Operative Pain
What is being tested?
Lower Insufflation Pressure and Standard Insufflation Pressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
10 Jun 2024to 10 Jun 2025
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 18 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 18 to 80
  • BMI 55.0 or less
  • Laparoscopic hysterectomy surgery planned

Who cannot join

  • Women younger than 18 or older than 80 years of age
  • BMI over 55.0
  • Laparoscopic hysterectomy surgery not planned

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38103

    Amira Wohabrebbi, PhD, 901-545-7453, awohabre@uthsc.edu

    Annette Hickerson, RN, 901-448-4784, abpayne@uthsc.edu

    Recruiting

Other trials in United States

About this study

The purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

Read the detailed description

This is a prospective, single-blinded, randomized clinical trial in which participants undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to undergo surgery with peritoneal insufflation pressure set to 15 mmHg (standard) or 12 mmHg (comparison). Randomization was performed using computer-generated permuted blocks of four participants. All participants on the first postoperative day will be asked to rate their pain with a Visual Analog Scale (VAS). At a postoperative visit 2 weeks after surgery, all participants will be asked to complete the VAS again. The highest preoperative pain (up to 2 hours before surgery) and immediate postoperative pain, using the VAS, in the post anesthesia care unit (PACU) will be recorded. All participants will be planned for discharge from PACU. Age, body mass index, gynecologic diagnosis, medical history, and preoperative analgesia or opioid use will be extracted from the medical records by trained research staff and entered into a secure electronic database. Preoperative analgesia and opioid saw will be verified with active prescription records at the time of surgery. After surgery, analgesic doses, operative time, additional procedures performed, conversion to laparotomy or increased insufflation pressure, estimated blood loss, and length of stay will be recorded.

Being tested
Lower Insufflation Pressure, Standard Insufflation Pressure
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Lower Insufflation PressureProcedure or surgery

    Participants underwent laparoscopic hysterectomy with an insufflation pressure that is lower than the standard insufflation pressure used in this type of surgery.

  • Standard Insufflation PressureProcedure or surgery

    Participants underwent laparoscopic hysterectomy with a standard insufflation pressure.

Study groups in NCT06508814
Study groupRoleWhat they receive
12 mmHg Insufflation PressureExperimentalParticipants received 12 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Receives: Procedure: Lower Insufflation Pressure
15 mmHg Insufflation PressureActive comparatorParticipants received 15 mmHg of insufflation pressure during their laparoscopic hysterectomy.
Receives: Procedure: Standard Insufflation Pressure

What is being measured

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

  1. Pain on postoperative day 1

    All participants will be asked to rate their pain using the Visual Analog Scale (VAS) approximately 24 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

    Measured: 24 hours following surgery

Secondary outcomes (4)

  1. Preoperative pain

    All participants will be asked to rate their pain using the Visual Analog Scale (VAS) upon their arrival before surgery. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

    Measured: Within 2 hours before surgery

  2. Postoperative pain while in PACU

    All participants will be asked to rate their pain using the Visual Analog Scale (VAS) while they are recovering in PACU, approximately 2 hours after surgery completion. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

    Measured: Approximately 2 hours after surgery completion

  3. Postoperative pain at follow-up visit

    All participants will be asked to rate their pain using the Visual Analog Scale (VAS) at their 2-week postoperative follow-up visit. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

    Measured: Approximately 2 weeks after surgery completion

  4. Opioid use after discharge

    All participants will be asked about the number of prescription opioid pills they took following discharge.

    Measured: Within 2 weeks after surgery

Timeline

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

  1. First posted18 Jul 2024
  2. Study start10 Jun 2024
  3. Primary completion10 Jun 2025 (estimated)
  4. Study completion10 Jun 2025 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508814
Sponsor's protocol ID
24-09977-FB
Status last verified
Jul 2024
First submitted
12 Jul 2024
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rustia GM, Baracy MG Jr, Khair E, Hagglund KH, Aslam MF. Pain With Differing Insufflation Pressures During Robotic Sacrocolpopexy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):151-159. doi: 10.1097/AOG.0000000000005231. Epub 2023 Jun 7.

    PubMed 37348093

  • Song T, Kim KH, Lee KW. The Intensity of Postlaparoscopic Shoulder Pain Is Positively Correlated with the Amount of Residual Pneumoperitoneum. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):984-989.e1. doi: 10.1016/j.jmig.2017.06.002. Epub 2017 Jun 7.

    PubMed 28602786

  • Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1):e2015.00113. doi: 10.4293/JSLS.2015.00113.

    PubMed 26955258

  • Grant A, Keltz J, Huang K. Is Decreased Insufflation Pressure During Major Robotic-Assisted Gynecologic Surgery Associated With Decreased Recovery Time and Patient Reported Pain Score. J Minim Invasive Gynecol. 2015 Nov-Dec;22(6S):S26. doi: 10.1016/j.jmig.2015.08.075. Epub 2015 Oct 15. No abstract available.

    PubMed 27679192

  • Topcu HO, Cavkaytar S, Kokanali K, Guzel AI, Islimye M, Doganay M. A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:81-5. doi: 10.1016/j.ejogrb.2014.09.003. Epub 2014 Sep 16.

    PubMed 25265495

  • Angioli R, Terranova C, Plotti F, Cafa EV, Gennari P, Ricciardi R, Aloisi A, Miranda A, Montera R, De Cicco Nardone C. Influence of pneumoperitoneum pressure on surgical field during robotic and laparoscopic surgery: a comparative study. Arch Gynecol Obstet. 2015 Apr;291(4):865-8. doi: 10.1007/s00404-014-3494-z. Epub 2014 Sep 27.

    PubMed 25260990

Questions about this trial

What is this clinical trial studying?

A study testing Lower Insufflation Pressure and Standard Insufflation Pressure in people with Post Operative Pain, run by University of Tennessee at 1 site in United States.

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 3 inclusion and 3 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 23 Jul 2024. 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 United States. 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on postoperative day 1 (time frame: 24 hours following 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 NCT06508814, 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 23 Jul 2024.

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