Post-operative PainNCT01720433
Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial
A study testing intervention in people with Post-operative Pain, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Feb 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients were recruited from a single Consultant's surgical clinic at the same District General Hospital between August 2010 and February 2012. This study was approved by the local ethics committee (National Research Ethics Service REC ref: 09/H0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. The trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation.
- The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (TAP). All procedures and data collection occurred at a District General Hospital.
Who cannot join
- The pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. Patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northampton General Hopsital
Northampton, Northamptonshire, NN15BD
About this study
Official title: Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.
Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique.
Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the Trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.
Read the detailed description
This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12 hour (P<0.01) and 24-hour (P<0.01) pain scores were significantly lower in the intervention group.
- Conditions
- Post-operative Pain
- Being tested
- intervention
- Keywords
- laparoscopic pain prospective blinded trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionProcedure or surgery
Also called pulmonary recruitment maneouvre
The patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | In the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment maneuver utilized, consisting of two manual inflations to a maximum pressure of 60 cm H2O. This was performed by the Anaesthetist, who held each positive pressure inflation for five seconds, with the valves on the operative ports fully open. Receives: Procedure: intervention |
| control arm | No intervention | In the control group residual carbon dioxide pneumo-peritoneum was evacuated at the end of the procedure by passively allowing the abdomen to decompress by opening the operative ports. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores at varying time points pot operatively
Pain scores were assessed by the use of a validated visual analogue score (whereby '0' was equivalent to 'no pain' and '10' equivalent to the worst 'conceivable pain.')
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northampton General Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achal Khanna, Northampton General Hospital NHS Trust
- Investigators
- Achal Khanna, MRCSEd, Principal investigator, Northampton General Hospital Northampton England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720433
- Sponsor's protocol ID
- lap pain trial NGH
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Khanna A, Sezen E, Barlow A, Rayt H, Finch JG. Randomized clinical trial of a simple pulmonary recruitment manoeuvre to reduce pain after laparoscopy. Br J Surg. 2013 Sep;100(10):1290-4. doi: 10.1002/bjs.9202.
PubMed 23939841
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Pain Following Laparoscopic Surgery: A Double Blind Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01720433
- Acronym / sponsor ID
- lap pain trial NGH
- Conditions
- Post-operative Pain
- Keywords
- laparoscopic pain prospective blinded trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Northampton General Hospital NHS TrustUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Nov 2012 (estimated)
- 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.
Shoulder tip and abdominal pain following laparoscopic procedures are well recognized as causes of post-operative morbidity. This prospective, double-blind, randomized controlled trial attempts to reduce post-operative pain in patients undergoing laparoscopic surgery by implementing a simple intra-operative technique.
Patients who undergo elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair will be recruited to the trial. Patients will be randomized to either the current standard (control group) or to receive an intervention to remove residual CO2. In the intervention group the pneumo-peritoneum will be removed, at the end of the operation, by placing the patient in the Trendelenburg position and utilising a pulmonary recruitment maneuver consisting of two manual inflations to a maximum pressure of 60 cm H2O. In the control group residual pneumo-peritoneum will be evacuated at the end of the procedure by passive decompression via the open operative ports.
Detailed description
This trial recruited 76 randomly assigned patients, 37 in the intervention group and 39 in the control group. The overall post-surgery pain scores, as analysed by two-way ANOVA, were significantly lower in the intervention group (P=0.0019). On Bonferroni post-tests both 12 hour (P<0.01) and 24-hour (P<0.01) pain scores were significantly lower in the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: interventionIn the intervention group, in addition to the above, the patient was placed in the Trendelenburg position (30°) and a pulmonary recruitment maneuver utilized, consisting of two manual inflations to a maximum pressure of 60 cm H2O. This was performed by the Anaesthetist, who held each positive pressure inflation for five seconds, with the valves on the operative ports fully open. |
| control arm | No intervention | –In the control group residual carbon dioxide pneumo-peritoneum was evacuated at the end of the procedure by passively allowing the abdomen to decompress by opening the operative ports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients were recruited from a single Consultant's surgical clinic at the same District General Hospital between August 2010 and February 2012. This study was approved by the local ethics committee (National Research Ethics Service REC ref: 09/H0405/65) and informed consent was obtained from all patients after they had the opportunity to study information leaflets that were also given to them. The trial was designed as a prospectively randomized and double blind trial with a 1:1 (control:intervention) allocation.
- The inclusion criteria was all adults with an American Society of Anesthesiologists (ASA) physical status grade 1 or 2, who were undergoing elective laparoscopic cholecystectomy for gallbladder disease or laparoscopic inguinal hernia repair performed as a transabdominal preperitoneal procedure (TAP). All procedures and data collection occurred at a District General Hospital.
Key exclusion criteria (2 listed)
- The pre-operative exclusion criteria included patients younger than 18 years, those who refused to give consent, those that had an inability to understand the research questionnaire and pregnancy. Patients who were found to require additional procedures, for example a conversion to open surgery, were excluded from the study prior to randomization.
- -
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 |
|---|---|---|
| interventionAlso: pulmonary recruitment maneouvreThe patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open. | Procedure or surgery | intervention |
Primary outcome
pain scores at varying time points pot operatively
Time frame: 48 hours
Pain scores were assessed by the use of a validated visual analogue score (whereby '0' was equivalent to 'no pain' and '10' equivalent to the worst 'conceivable pain.')
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 2 Nov 2012.
- Derived from this study: PubMed 23939841Khanna A, Sezen E, Barlow A, Rayt H, Finch JG. Randomized clinical trial of a simple pulmonary recruitment manoeuvre to reduce pain after laparoscopy. Br J Surg. 2013 Sep;100(10):1290-4. doi: 10.1002/bjs.9202.
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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.
Achal Khanna, MRCSEd principal investigator
Northampton General Hospital Northampton England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention in people with Post-operative Pain, run by Northampton General Hospital NHS Trust at 1 site in United Kingdom.
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 2 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 2 Nov 2012. 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 Kingdom. 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?
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?
pain scores at varying time points pot operatively (time frame: 48 hours). 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 NCT01720433, which also lists 1 linked publication.
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 2 Nov 2012.