Postoperative Shoulder Pain After Gynecologic Laparoscopy
Conditions
Keywords
Laparoscopy, Shoulder Pain, Postoperative Pain, Carbon Dioxide Retention, Intraperitoneal Gas Drain, Gynecologic Surgery, Visual Analog Scale (VAS)
Brief summary
This randomized controlled trial aims to evaluate whether the use of an intraperitoneal gas drain at the end of gynecologic laparoscopic surgery can reduce postoperative shoulder pain. Residual carbon dioxide after laparoscopy is believed to irritate the diaphragm and cause referred shoulder pain, which is a common and distressing postoperative symptom. Women undergoing gynecologic laparoscopy lasting more than 20 minutes will be randomized to receive either an intraperitoneal drain for passive gas evacuation or standard care without a drain. Shoulder pain, abdominal pain, analgesic consumption, postoperative nausea and vomiting, and recovery indicators will be assessed during the first 48 hours after surgery.
Detailed description
Post-laparoscopic shoulder pain is a frequent complaint after gynecologic laparoscopy and is mainly attributed to residual carbon dioxide retained in the peritoneal cavity, which irritates the diaphragm and stimulates the phrenic nerve. This study is designed to investigate a simple mechanical intervention-placement of an intraperitoneal gas drain-to facilitate passive evacuation of carbon dioxide and potentially reduce postoperative pain. Women undergoing gynecologic laparoscopy lasting more than 20 minutes at the Department of Obstetrics and Gynecology, Women's Health University Hospital, Assiut University, will be recruited and randomized into two equal groups. The intervention group will receive a plastic intraperitoneal drain placed through the umbilical port and left in situ for 24 hours postoperatively. The control group will undergo standard gas evacuation without drain placement. Pain will be assessed using a 10-cm Visual Analog Scale (VAS) at recovery, 6, 12, 24, and 48 hours postoperatively for both shoulder and abdominal pain. Secondary outcomes include total analgesic consumption within 48 hours, incidence of postoperative nausea and vomiting, time to return of intestinal sounds, and time to first mobilization. The primary outcome is the mean shoulder pain score at 24 hours. This trial aims to provide high-quality evidence on the effectiveness of intraperitoneal gas drainage in reducing postoperative discomfort following gynecologic laparoscopy.
Interventions
OTHERIntraperitoneal Gas Drain
A plastic intraperitoneal drain is placed through the umbilical port at the end of laparoscopic surgery and left in situ for 24 hours to allow passive evacuation of carbon dioxide. This aims to reduce diaphragmatic irritation and postoperative shoulder pain.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized into two parallel groups: one receiving intraperitoneal gas drainage and one receiving standard care without drainage.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women undergoing gynecologic laparoscopy lasting more than 20 minutes. * Able and willing to provide informed consent.
Exclusion criteria
* Refusal to participate. * Patients unable to give consent or unable to participate in pain assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of postoperative shoulder pain using the Visual Analog Scale (VAS) | At 24 hours after surgery | Shoulder pain severity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative shoulder pain (VAS) at 12 hours | At 12 hours after surgery | Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Postoperative shoulder pain (VAS) at 24 hours | At 24 hours after surgery | Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Postoperative shoulder pain (VAS) at 48 hours | At 48 hours after surgery | Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Postoperative shoulder pain (VAS) at 6 hours | At 6 hours after surgery | Pain severity will be measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
| Incidence of postoperative nausea and vomiting | Up to 48 hours after surgery | Number of participants experiencing nausea and/or vomiting within 48 hours after surgery. |
| Time to return of bowel sounds | Up to 48 hours after surgery | Time from end of surgery until the first documented return of bowel sounds. |
| Time to first mobilization | Up to 48 hours after surgery | Time from end of surgery until first ambulation. |
| Total analgesic consumption within 48 hours | Up to 48 hours after surgery | Total amount of opioids and NSAIDs administered during the first 48 hours after surgery will be recorded. |
Contacts
Primary ContactMohamed Shehata Mohamed Osman
Backup ContactAbdulrahmen Mohamed Rageh, MD
Outcome results
None listed